Initial experience with SelectMDx® in the diagnosis of prostate cancer in a real-world evidence clinical practice setting | Actas Urológicas Españolas (English Edition)

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The combination of biomarkers and described clinical data predicts the probability of clinically significant prostate cancer and prostate cancer. PCa: prostate cancer; PSA: prostate specific antigen; mpMRI: multiparametric magnetic resonance imaging." ] ] ] "textoCompleto" => "IntroductionThe diagnosis of prostate cancer (PCa) has been under constant evolution in recent years, promoted by the incorporation of the multiparametric magnetic resonance image (mpMRI) and hindered by the overdiagnosis alert produced by the ERSPC and PLCO studies.<a class="elsevierStyleCrossRefs" href="#bib0005">1,2</a> With the implementation of prostate specific antigen (PSA) as a diagnostic parameter in the eighties, the incidence of PC has exponentially increased until becoming the most frequent tumor in men.<a class="elsevierStyleCrossRef" href="#bib0015">3</a> Even when the use of this tissue marker has increased the incidence of PCa, its sensitivity as an independent screening test is limited and controversial. Along with PSA, digital rectal examination and transrectal prostate biopsy (PB) are the diagnostic pillars of PCa.If we rely on PSA alone, PB is indicated from values above 4 ng/mL.<a class="elsevierStyleCrossRef" href="#bib0020">4</a> When PSA ranges between 4 and 10 ng/mL, the rate of negative transrectal biopsies reaches 65%–70% of the cases<a class="elsevierStyleCrossRef" href="#bib0025">5</a> and, in turn, 10%–35% of second biopsies will also be negative.<a class="elsevierStyleCrossRef" href="#bib0030">6</a> This means that unnecessary PBs are being performed, being a procedure that is not exempt of complications.<a class="elsevierStyleCrossRef" href="#bib0035">7</a>Another limitation of PSA tests is that their value does not correlate with the risk of being diagnosed with PCa or tumor aggressiveness. About 70% of the patients diagnosed with PCa based on PSA rise have a biopsy Gleason ≤ 6.<a class="elsevierStyleCrossRef" href="#bib0005">1</a> For these reason, the development of new tools that allow us to diagnose clinically significant tumors (CS-PCa) with greater precision and avoid unnecessary PB which lead to over-diagnosis and overtreatment of non-significant PC is crucial.<a class="elsevierStyleCrossRef" href="#bib0040">8</a>The first tests developed with this intention, such as the PCA3<a class="elsevierStyleCrossRef" href="#bib0045">9</a> or the PHI-score,<a class="elsevierStyleCrossRef" href="#bib0050">10</a> were based solely on the assessment of biomarkers to calculate the overall risk of detecting PCa in a biopsy. Over time, new tests such as SelectMDx<a class="elsevierStyleCrossRef" href="#bib0055">11</a> or 4 K-score<a class="elsevierStyleCrossRef" href="#bib0060">12</a> have emerged. These combine the study of biomarkers together with clinical characteristics of the patient in order to offer a more accurate and individualized prediction of the risk of suffering, not only overall PCa, but significant PCa. SelectMDx® is a urinary molecular detection test for PCa. It is based on the analysis of 2 genes (HOXC6 and DLX1) that are frequently overexpressed in cases of PC with Gleason ≥ 7.<a class="elsevierStyleCrossRef" href="#bib0065">13</a> When combined with the patient’s clinical risk factors (PSA, digital rectal examination, prostate volume, previous negative PB and first-degree family history of PCa), this test allows us to calculate the probability of risk of suffering CS-PCa, even in patients with PSA < 10 ng/mL.<a class="elsevierStyleCrossRef" href="#bib0070">14</a> The test has been validated in a prospective multicenter study<a class="elsevierStyleCrossRef" href="#bib0055">11</a> for the detection of Gleason ≥ 7 PCa using ultrasound-guided transrectal PB. Its power lies in its high negative predictive value of 98%, with sensitivity and specificity values of 96% and 53%, respectively. The application of this test prior to the first biopsy or previous indication of second biopsies adds individualized information on the risk of detecting CS-PCa.With an initial experience in a center specialized in the comprehensive management of PCa, we analyzed, with "real-world evidence" (RWE), the utility and applicability of the SelectMDx® marker in the diagnosis of CS-PCa.Material and methodsRetrospective descriptive study of the cases analyzed with SelectMDx® test between July 2017 and April 2019. The eligibility criteria for the patients who were offered to receive the test were: 1) patients with a previous negative biopsy and negative or doubtful mpMRI (PIRADS 3 lesions) who may forego a repeat biopsy procedure; 2) assessment of the first biopsy in patients with suspected PCa and negative or doubtful mpMRI; 3) patients who demand the test seeking a second opinion in our center. Suspicion of PCa was defined by PSA > 4 ng/mL rise, pathological rectal examination and/or presence of PIRADS 4–5 lesions in the mpMRI. The clinical parameters collected were age, family history of PCa, digital rectal examination, previous PB (systematic transrectal, cognitive transrectal or transperineal fusion) and mpMRI prior to the test. Other parameters included in the analysis were: PSA, PSA density and prostate volume. Patients with a history of PCa and those who were on treatment with 5-alpha reductase inhibitors were excluded from the study. A prostate massage was performed prior to collecting urine samples. The samples were sent to the central laboratory with the additional information requested (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>) and the probability of presenting a PCa and a CS-PCa was calculated with the combination of biomarkers and clinical parameters.<elsevierMultimedia ident="fig0005"></elsevierMultimedia>We stratified our patients into two groups according to the result obtained: patients with a very low risk of CS-PCa (<2% according to the results of the test) and patients with a higher risk of CS-PCa (>2%). In order to evaluate the agreement between both tests, we compared the data to determine the risk of CS-PCa obtained by the SelectMDx® test and that obtained with the ERSPC calculator. Finally, we collected the additional tests and subsequent treatments received based on the previously described group.ResultsThe SelectMDx® test was performed on a total of 51 patients, of whom 3 cases were excluded for being under 5-alpha reductase inhibitors treatment. Patients baseline characteristics are described in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>. The techniques for the performance of the biopsy in the 14 patients (29%) who had at least one previous negative PB were as follows: systematic transrectal (6 patients), cognitive transrectal (2 patients) and transperineal fusion (6 patients). For the review of the results, patients will be classified into groups based on the history of PB and mpMRI (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>).<elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia>Patients with a previous negative biopsy and negative or doubtful mpMRI (group a)Fourteen patients (29%) had at least one previous negative PB, of which 12 had one mpMRI; in 9 cases the results were normal or presented PIRADS ≤ 3 lesions. In other words, a total of 9 patients belong to this group (the remaining patients with a previous negative biopsy are analyzed in the paragraphs corresponding to groups b y c). In this group of patients, the test showed a very low risk of CS-PCa in 7/9 cases; the 2 cases of greatest risk had a pathological rectal examination. A transperineal fusion biopsy was performed in one of these 2 patients, showing a result of atypical microacinar proliferation.Patients with previous negative biopsy and suspicious mpMRI (group b)Of the 3 patients who presented a PIRADS 4 lesions in the mpMRI, one of them showed a very low risk of PCa and the other 2 presented a PCa probability of 58% and 68% and Gleason ≥ 7 in 30% and 39%, respectively. MpMRI was repeated to the patient with low-risk, and his lesion was restaged to PIRADS 2. One of the patients underwent a second biopsy in our center and was diagnosed with Gleason 3 + 4 PCa and treated with radiotherapy and androgen blockade.Patients with previous negative biopsy without mpMRI (group c)One of these two patients obtained "very low risk of PCa", and the other patient had 35% for PCa and 11% for CS-PCa. This patient had a pathological digital rectal examination.Patients without previous biopsy with negative or doubtful mpMRI (group d)This group includes 18 patients; twelve presented a test result of «very low risk of PCa» and in the other 6 cases, the probability of PCa ranged between 35 and 44%, and the probability of CS-PCa between 11 and 18%. Two of the patients with >2% risk underwent/received a prostate biopsy in our center: one detected a Gleason 3 + 3 PCa and the other one a Gleason 3 + 4 PCa, which were treated with focal therapy (irreversible electroporation) and radical prostatectomy, respectively.Patients without a previous biopsy with suspicious mpMRI (group e)Only 2 patients presented PIRADS 4 lesions, with a result of «very low risk of PC» in one of the 2 cases. It should be noted that the case with a higher risk presented a positive digital rectal examination.Patients without previous biopsy or mpMRI (group f)Of the 14 patients in this group, 9 patients presented a «very low risk of PC» result, and the remaining 5 patients obtained a probability of 43%–92% for PCa and 17%–68% for CS-PCa. Two of these patients underwent a mpMRI after receiving the test, showing PIRADS 2 and PIRADS 4 lesions with Gleason 3 + 3 and Gleason 3 +  lesions after biopsy, respectively. The latter was treated by radical prostatectomy.Patients with positive digital rectal examination (group g)We must highlight that regardless of the other clinical-radiological parameters and having a previous biopsy, the 12 patients who presented a pathological rectal examination showed a risk of CS-PCa > 2% in the test, with values of 35%–92% for PCa and 11%–68% for CS-PCa.The comparison of the risk of PCa determined by the test and by the ERSPC calculator is shown in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>. Only one of those patients who had a very low risk of presenting a CS-PCa in the test received a mpMRI after the test, which turned out to be negative. The remaining patients were followed up with PSA tests and did not require subsequent PBs. The median follow-up of this cohort of patients after the performance of the test is 15.1 months. To date, we have no suspicion or evidence of the appearance of CS-PCa in any of these patients.DiscussionThe development of new molecular tests, together with the implementation of mpMRI, represent a change in the diagnostic approach of patients with suspected PCa. Until the appearance of these tests, the decision to perform a PB was based on the PSA levels and their derived calculations (free PSA/total PSA ratio, PSA density, PSA doubling time) and digital rectal examination. The first biomarker available for the diagnosis of PCa was Progensa PCA3,<a class="elsevierStyleCrossRef" href="#bib0045">9</a> followed by the "Prostate Health Index score" (PHI-score).<a class="elsevierStyleCrossRef" href="#bib0050">10</a> These first molecular tests are mainly based on the biomarker analyzed and globally predict the probability of detecting PCa. Subsequently, new molecular tests such as the 4 K score,<a class="elsevierStyleCrossRef" href="#bib0060">12</a> Select-MDx®<a class="elsevierStyleCrossRef" href="#bib0055">11</a> or MiPS<a class="elsevierStyleCrossRef" href="#bib0075">15</a> have emerged on the market, which have two main advantages over their predecessors: 1) the combination of clinical parameters together with the evaluation of the biomarker that give a more accurate result; 2) they do not only predict the probability of finding any PCa on biopsy, they also predict whether this tumor is CS-PCa. Implementing the use of these tests into routine clinical practice allows us to expand the possibilities of determining which patients will really benefit from PB. This is essential to avoid unnecessary biopsies.SelectMDx® is a minimally invasive test, which has shown to reliably detect those patients with a very low risk of CS-PCa. The test has a negative predictive value of 98%, with a probability of not detecting a CS-PCa of only 2% and achieving a biopsy avoidance rate of 53%.<a class="elsevierStyleCrossRef" href="#bib0055">11</a> These data are comparatively better than the rest of the biomarkers available on the market (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>).<elsevierMultimedia ident="tbl0015"></elsevierMultimedia>With the clear objective of studying the usefulness and applicability of the test in real clinical practice, instead of its sensitivity, and given the heterogeneity of the use of the test, the extrapolation of results in a small sample such as ours is limited. However, based on the groups with the largest number of patients, we consider that the following are interesting observations:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005">none-In group a), the test showed a very low risk in 7 cases, so the corresponding biopsies were avoided. The test presented a higher result in two cases only, and the biopsy of one of them showed atypical microacinar proliferation. Despite the limited follow-up time, we believe that the test is reliable in this patient profile.</li><li class="elsevierStyleListItem" id="lsti0010">none-Group d) was the largest of the sample (18 patients), with 12 patients with a very low risk of PCa. PCa was detected in 2 of the 6 patients with a higher risk; one was CS-PCa. Although the sample is not high, we do believe that in this clinical setting, the test can provide useful information in the management of these patients.</li><li class="elsevierStyleListItem" id="lsti0015">none-Of the 14 patients in group f), the test showed a result of risk >2% in 5 patients, and 2 of them were diagnosed with PCa. Even if this indication is not included in the guidelines, it is interesting to note that the test can also be useful in these patients, for example in settings where mpMRI is not available.</li><li class="elsevierStyleListItem" id="lsti0020">none-The number of patients included in the remaining groups (b, c and e) is too small for drawing conclusions.</li><li class="elsevierStyleListItem" id="lsti0025">none-We must highlight that the test showed a risk of suffering PCa > 2% in the 12 patients who presented a pathological rectal examination. Data regarding the impact of digital rectal examination on the test are scarce. Trooskens et al.<a class="elsevierStyleCrossRef" href="#bib0115">23</a> carried out a study that calculated sensitivity, specificity and negative predictive value when one or more of the clinical parameters collected in the test were missing, including digital rectal examination. They conclude that despite excluding one or more variables, the sensitivity and negative predictive value of the test do not decrease, but its specificity does decrease.</li></ul>MpMRI is an imaging test with high sensitivity and a negative predictive value for PCa detection.<a class="elsevierStyleCrossRefs" href="#bib0120">24,25</a> However, even though the use of this test is increasingly widespread, the interobserver variability remains high and around 15% of CS-PCa are not detected by this test. The use of molecular tests together with mpMRI provides an interesting additional diagnostic value in the management of these patients and can detect cases of CS-PCa that are not detected by imaging. Studies like the one of Hendriks et al.<a class="elsevierStyleCrossRef" href="#bib0130">26</a> show the correlation between the results of the mpMRI and SelectMDx®, and the result of SelectMDx® was significantly higher in patients with PIRADS 4–5 lesions. In addition, this study shows how the sensitivity and specificity of the combination of SelectMDx® and mpMRI is greater than the combination of the imaging test with PSA or PCA3.This study presents a series of limitations to take into account: 1) short follow-up time to confirm that patients with a negative result are not subsequently diagnosed with PCa; 2) loss of follow-up in some patients; 3) the cost/price of the test can generate selection bias. SelectMDx® test is currently not funded, therefore it implies a direct cost to the patient. However, published studies have demonstrated the cost-effectiveness of the test in several European countries, including Spain, with a gain in quality-adjusted life years (QALY) of 0.020 and savings of 247 є per patient.<a class="elsevierStyleCrossRef" href="#bib0135">27</a>Another limiting factor of the study is not having a radiological and/or histological verification to corroborate the test in most cases. However, these studies have been previously carried out,<a class="elsevierStyleCrossRefs" href="#bib0055">11,28</a> and it was not the objective of our work.This study represents the first study on the use of SelectMDx® implemented into the usual clinical practice of a center in our setting, with a sufficient number of patients to draw initial conclusions. Based on our results, we believe that the two main scenarios in which the use of SelectMDx® is contemplated would be those patients with suspected PCa, without a biopsy or with a history of negative PB, with normal or doubtful mpMRI (PIRADS ≤ 3) (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>).<elsevierMultimedia ident="fig0010"></elsevierMultimedia>ConclusionSelectMDx® is a promising test for the detection of very low risk of CS-PCa. Its use in routine clinical practice is a very convenient tool, especially in patients with suspected PCa with or without previous negative biopsies, in which the mpMRI shows a normal or doubtful result. The presence of a pathological digital rectal examination can condition the test result, with an overestimation of PCa risk. These results must be validated by further studies with a larger sample.Conflicts of interestThe authors declare that they have no conflicts of interest." "textoCompletoSecciones" => array:1 [ "secciones" => array:11 [ 0 => array:3 [ "identificador" => "xres1378863" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Material and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1266518" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1378862" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Material y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusión" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1266519" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Material and methods" ] 6 => array:3 [ "identificador" => "sec0015" "titulo" => "Results" "secciones" => array:7 [ 0 => array:2 [ "identificador" => "sec0020" "titulo" => "Patients with a previous negative biopsy and negative or doubtful mpMRI (group a)" ] 1 => array:2 [ "identificador" => "sec0025" "titulo" => "Patients with previous negative biopsy and suspicious mpMRI (group b)" ] 2 => array:2 [ "identificador" => "sec0030" "titulo" => "Patients with previous negative biopsy without mpMRI (group c)" ] 3 => array:2 [ "identificador" => "sec0035" "titulo" => "Patients without previous biopsy with negative or doubtful mpMRI (group d)" ] 4 => array:2 [ "identificador" => "sec0040" "titulo" => "Patients without a previous biopsy with suspicious mpMRI (group e)" ] 5 => array:2 [ "identificador" => "sec0045" "titulo" => "Patients without previous biopsy or mpMRI (group f)" ] 6 => array:2 [ "identificador" => "sec0050" "titulo" => "Patients with positive digital rectal examination (group g)" ] ] ] 7 => array:2 [ "identificador" => "sec0055" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0060" "titulo" => "Conclusion" ] 9 => array:2 [ "identificador" => "sec0065" "titulo" => "Conflicts of interest" ] 10 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2019-09-15" "fechaAceptado" => "2020-03-22" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1266518" "palabras" => array:3 [ 0 => "Prostate cancer" 1 => "Diagnosis" 2 => "Biomarker" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1266519" "palabras" => array:3 [ 0 => "Cáncer de próstata" 1 => "Diagnóstico" 2 => "Marcador" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "IntroductionThe use of biomarkers in the detection of prostate cancer (PC) can decrease overdiagnosis and overtreatment of non-significant PC. We analyze the usefulness and applicability of the SelectMDx® marker in a routine clinical practice setting. Material and methodsRetrospective study of 48 patients evaluated by the SelectMDx® test between July 2017 and April 2019. Patients were stratified into two groups according to the risk estimated by the clinically significant CP test (CS-PC): <2% or "very low risk", and >2%. Results were expressed based on previous prostate biopsy (PB) and MRI outcomes. ResultsPatients with negative PB and normal/doubtful MRI had <2% risk in 7/9 cases. Patients without PB and normal/doubtful MRI had <2% risk in 12/18 cases, and 2/6 cases with a >2% risk presented CS-PC. Of the 14 patients with no previous PB or MRI, 9 had <2% risk, and 2 cases were diagnosed with PC from the group of patients (5) with risk >2%. The number of patients in the remaining subgroups is too small to draw any conclusions. In all cases with pathological digital rectal examination, the test showed a >2% PC risk. ConclusionSelectMDx® is a promising test for detecting patients with a very low risk of CS-PC, especially in patients with suspected PC, with or without negative PB, with normal/doubtful MRI. The presence of a pathological digital rectal examination may condition the result of the test." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Material and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "IntroducciónEl uso de biomarcadores en la detección del cáncer de próstata (CP) puede disminuir el sobrediagnóstico y sobretratamiento de CP no significativos. Analizamos la utilidad y aplicabilidad del marcador SelectMDx® en un entorno de práctica clínica habitual. Material y métodosEstudio retrospectivo de 48 pacientes evaluados mediante el test SelectMDx® entre julio de 2017 y abril de 2019. Los pacientes se estratificaron en dos grupos según el riesgo estimado por el test de CP clínicamente significativo (CP-CS): <2% o “muy bajo riesgo”, y >2%. Los resultados se expresaron en función de los antecedentes de biopsia prostática (BP) y RMmp. ResultadosEn pacientes con BP negativa y RMmp normal/dudosa el riesgo fue <2% en 7/9 casos. En pacientes sin BP y RMmp normal/dudosa el riesgo fue <2% en 12/18 casos, y 2/6 casos con un riesgo >2% presentaron un CP-CS. De los 14 pacientes sin BP ni RMmp previas, 9 presentaron un riesgo <2%, con 2 casos diagnosticados de CP en los 5 pacientes con riesgo >2%. En el resto de subgrupos el número de pacientes es pequeño como para poder extraer conclusiones. En todos los casos con tacto rectal patológico el test demostraba un riesgo de padecer CP > 2%. ConclusiónSelectMDx® es un test prometedor para detectar pacientes con un riesgo muy bajo de CP-CS, especialmente en pacientes con sospecha de CP con o sin BP negativas, en los que la RMmp muestre un resultado normal/dudoso. La presencia de un tacto rectal patológico puede condicionar el resultado del test." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Material y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusión" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Quintana LM, Fernández Pascual E, Linares Espinós E, Martinez-Ballesteros C, Martin-Vivas C, Rengifo Abbad D, et al. Experiencia inicial del uso de SelectMDx® en el diagnóstico de cáncer de próstata en un entorno de práctica clínica habitual «real-world evidence». Actas Urol Esp. 2020;44:400–407." ] ] "multimedia" => array:5 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 3401 "Ancho" => 3000 "Tamanyo" => 331578 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "The patients selected to undergo the test receive a prostate massage prior to obtaining the urine sample. The combination of biomarkers and described clinical data predicts the probability of clinically significant prostate cancer and prostate cancer. PCa: prostate cancer; PSA: prostate specific antigen; mpMRI: multiparametric magnetic resonance imaging." ] ] 1 => array:8 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 991 "Ancho" => 1491 "Tamanyo" => 70201 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0010" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "Algorithm for use proposed for the implementation of SelectMDx® in routine clinical practice. PCa: prostate cancer; PSA: prostate specific antigen; mpMRI: multiparametric magnetic resonance imaging." ] ] 2 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0015" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "Data on age, PSA, prostate volume, and PSA density are expressed as medians (interquartile range).PCa: prostate cancer; PSA: prostate specific antigen; mpMRI: multiparametric magnetic resonance imaging." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Age \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">62 (58−70) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">PCa family history \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">17% (8/48) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">PSA, ng/mL \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6,5 (5−15,5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Prostate volume, cm3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">60 (45−78) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">PSA density \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0,11 (0,08–0,16) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Pathological rectal examination \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">25% (12/48) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Previous negative biopsy \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">29% (14/48) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Previous mpMRI \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">65% (31/48) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">PIRADS 4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5/31 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">PIRADS ≤ 3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26/31 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2367619.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Baseline characteristics of the patients in the sample." ] ] 3 => array:8 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0020" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "mpMRI: multiparametric magnetic resonance imaging." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Clinical scenario \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">SelectMDx® risk ≤ 2%/> 2% (total) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">ERSPC calculator biopsy indication No/Yes (total) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Data agreement (%) \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Negative biopsy - mpMRI PIRADS ≤ 3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 / 2 (9) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 / 3 (8) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 / 8 (87,5%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Negative biopsy - mpMRI PIRADS ≥ 4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 / 2 (3) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 / 2 (2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 / 2 (50%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Negative biopsy - No mpMRI \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 / 1 (2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 / 1 (2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 / 2 (100%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No biopsy - mpMRI PIRADS ≤ 3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12 / 6 (18) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">14 / 1 (15) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">11 / 15 (73%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No biopsy - mpMRI PIRADS ≥ 4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 / 1 (2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 / 1 (2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 / 2 (100%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No biopsy - No mpMRI \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">9 / 5 (14) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 / 3 (6) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6 / 6 (100%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Pathological rectal examination \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 / 12 (12) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 / 8 (10) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8 / 10 (80%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Total \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">38 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">31 / 38 (82%) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2367620.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Stratified results according to diagnostic process and risk percentage." ] ] 4 => array:8 [ "identificador" => "tbl0015" "etiqueta" => "Table 3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0025" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "AUC: area under the curve; CS-PCa: clinically significant prostate cancer; fPSA: free PSA; tPSA: total PSA; NPV: negative predictive value." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Test \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Biomarker \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Sample \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Diagnostic accuracy \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Progensa PCA3<a class="elsevierStyleCrossRefs" href="#bib0045">9,16–18</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">PCA3 and PSA mRNA \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Urine \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">NPV: 88%−90%; AUC: 0.66−0.69 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Risk of not detecting CS-PCa: 10%−12% \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Avoids 44% biopsies \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">PHI score<a class="elsevierStyleCrossRefs" href="#bib0050">10,19,20</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">tPSA, PSAl, p2PSA \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Blood \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">NPV: 67%−92%; AUC: 0.7−0.77 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Risk of not detecting CS-PCa: 8%−33% \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Avoids 36% biopsies \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 K score<a class="elsevierStyleCrossRef" href="#bib0060">12</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">tPSA, fPSA, intact PSA, hK2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Blood \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">VPN: 95%; AUC: 0.82 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Risk of not detecting CS-PCa: 5% \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Avoids 36% biopsies \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">MiPS<a class="elsevierStyleCrossRef" href="#bib0075">15</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">tPSA, PCA3 mRNA, and TMPRSS2-ERG \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Urine \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">AUC: 0,77 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No data available on the other variables \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">SelectMDx<a class="elsevierStyleCrossRef" href="#bib0055">11</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">HOXC6 and DLX1 mRNA \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Urine \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">VPN: 98%; AUC: 0.86 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Risk of not detecting CS-PCa: 2% \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Avoids 53% biopsies \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">ConfirmMDx<a class="elsevierStyleCrossRef" href="#bib0105">21</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">GSTP1, APC and RASSF gene methylation \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Prostate biopsy \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">NPV: 96%; AUC: 0.74 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Risk of not detecting CS-PCa: 4% \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">ExoDx<a class="elsevierStyleCrossRef" href="#bib0110">22</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">PCA3, ERG and SPDEF mRNA \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Urine \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">NPV: 91%; AUC: 0.73 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Risk of not detecting CS-PCa: 9% \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Avoids 27% biopsies \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2367618.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Characteristics of the molecular tests available on the market." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:28 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Screening and prostate-cancer mortality in a randomized European study" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "F.H. 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Original article

Initial experience with SelectMDx® in the diagnosis of prostate cancer in a real-world evidence clinical practice setting

Experiencia inicial del uso de SelectMDx® en el diagnóstico de cáncer de próstata en un entorno de práctica clínica habitual «real-world evidence»

L.M. Quintanaa, E. Fernández Pascuala,b, E. Linares Espinósa,b,

Corresponding author

elinares@lyxurologia.com

Corresponding author.

, C. Martinez-Ballesterosb,c, C. Martin-Vivasb, D. Rengifo Abbadb,c, N. D’Anna Carusob, A. Allonad, J.I. Martínez-Salamancab,c

a Servicio de Urología, Hospital Universitario La Paz, Universidad Autónoma de Madrid, Madrid, Spain

b Instituto Lyx Urología, Universidad Francisco de Vitoria, Madrid, Spain

c Servicio de Urología, Hospital Universitario Puerta de Hierro-Majadahonda, Universidad Autónoma de Madrid, Madrid, Spain

d Servicio de Urología, Hospital Ruber Internacional, Madrid, Spain

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        "titulo" => "Experiencia inicial del uso de SelectMDx&#174; en el diagn&#243;stico de c&#225;ncer de pr&#243;stata en un entorno de pr&#225;ctica cl&#237;nica habitual &#171;real-world evidence&#187;"
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The patients selected to undergo the test receive a prostate massage prior to obtaining the urine sample&#46; The combination of biomarkers and described clinical data predicts the probability of clinically significant prostate cancer and prostate cancer&#46;</p> <p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">PCa&#58; prostate cancer&#59; PSA&#58; prostate specific antigen&#59; mpMRI&#58; multiparametric magnetic resonance imaging&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">The diagnosis of prostate cancer &#40;PCa&#41; has been under constant evolution in recent years&#44; promoted by the incorporation of the multiparametric magnetic resonance image &#40;mpMRI&#41; and hindered by the overdiagnosis alert produced by the ERSPC and PLCO studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a> With the implementation of prostate specific antigen &#40;PSA&#41; as a diagnostic parameter in the eighties&#44; the incidence of PC has exponentially increased until becoming the most frequent tumor in men&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> Even when the use of this tissue marker has increased the incidence of PCa&#44; its sensitivity as an independent screening test is limited and controversial&#46; Along with PSA&#44; digital rectal examination and transrectal prostate biopsy &#40;PB&#41; are the diagnostic pillars of PCa&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">If we rely on PSA alone&#44; PB is indicated from values above 4&#8239;ng&#47;mL&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> When PSA ranges between 4 and 10&#8239;ng&#47;mL&#44; the rate of negative transrectal biopsies reaches 65&#37;&#8211;70&#37; of the cases<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> and&#44; in turn&#44; 10&#37;&#8211;35&#37; of second biopsies will also be negative&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> This means that unnecessary PBs are being performed&#44; being a procedure that is not exempt of complications&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Another limitation of PSA tests is that their value does not correlate with the risk of being diagnosed with PCa or tumor aggressiveness&#46; About 70&#37; of the patients diagnosed with PCa based on PSA rise have a biopsy Gleason&#8239;&#8804;&#8239;6&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> For these reason&#44; the development of new tools that allow us to diagnose clinically significant tumors &#40;CS-PCa&#41; with greater precision and avoid unnecessary PB which lead to over-diagnosis and overtreatment of non-significant PC is crucial&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The first tests developed with this intention&#44; such as the PCA3<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> or the PHI-score&#44;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> were based solely on the assessment of biomarkers to calculate the overall risk of detecting PCa in a biopsy&#46; Over time&#44; new tests such as SelectMDx<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> or 4&#8239;K-score<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> have emerged&#46; These combine the study of biomarkers together with clinical characteristics of the patient in order to offer a more accurate and individualized prediction of the risk of suffering&#44; not only overall PCa&#44; but significant PCa&#46; SelectMDx&#174; is a urinary molecular detection test for PCa&#46; It is based on the analysis of 2 genes &#40;HOXC6 and DLX1&#41; that are frequently overexpressed in cases of PC with Gleason&#8239;&#8805;&#8239;7&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> When combined with the patient&#8217;s clinical risk factors &#40;PSA&#44; digital rectal examination&#44; prostate volume&#44; previous negative PB and first-degree family history of PCa&#41;&#44; this test allows us to calculate the probability of risk of suffering CS-PCa&#44; even in patients with PSA &#60;&#8239;10&#8239;ng&#47;mL&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> The test has been validated in a prospective multicenter study<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> for the detection of Gleason&#8239;&#8805;&#8239;7 PCa using ultrasound-guided transrectal PB&#46; Its power lies in its high negative predictive value of 98&#37;&#44; with sensitivity and specificity values of 96&#37; and 53&#37;&#44; respectively&#46; The application of this test prior to the first biopsy or previous indication of second biopsies adds individualized information on the risk of detecting CS-PCa&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">With an initial experience in a center specialized in the comprehensive management of PCa&#44; we analyzed&#44; with &#34;real-world evidence&#34; &#40;RWE&#41;&#44; the utility and applicability of the SelectMDx&#174; marker in the diagnosis of CS-PCa&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Material and methods</span><p id="par0030" class="elsevierStylePara elsevierViewall">Retrospective descriptive study of the cases analyzed with SelectMDx&#174; test between July 2017 and April 2019&#46; The eligibility criteria for the patients who were offered to receive the test were&#58; 1&#41; patients with a previous negative biopsy and negative or doubtful mpMRI &#40;PIRADS 3 lesions&#41; who may forego a repeat biopsy procedure&#59; 2&#41; assessment of the first biopsy in patients with suspected PCa and negative or doubtful mpMRI&#59; 3&#41; patients who demand the test seeking a second opinion in our center&#46; Suspicion of PCa was defined by PSA&#8239;&#62;&#8239;4&#8239;ng&#47;mL rise&#44; pathological rectal examination and&#47;or presence of PIRADS 4&#8211;5 lesions in the mpMRI&#46; The clinical parameters collected were age&#44; family history of PCa&#44; digital rectal examination&#44; previous PB &#40;systematic transrectal&#44; cognitive transrectal or transperineal fusion&#41; and mpMRI prior to the test&#46; Other parameters included in the analysis were&#58; PSA&#44; PSA density and prostate volume&#46; Patients with a history of PCa and those who were on treatment with 5-alpha reductase inhibitors were excluded from the study&#46; A prostate massage was performed prior to collecting urine samples&#46; The samples were sent to the central laboratory with the additional information requested &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41; and the probability of presenting a PCa and a CS-PCa was calculated with the combination of biomarkers and clinical parameters&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">We stratified our patients into two groups according to the result obtained&#58; patients with a very low risk of CS-PCa &#40;&#60;2&#37; according to the results of the test&#41; and patients with a higher risk of CS-PCa &#40;&#62;2&#37;&#41;&#46; In order to evaluate the agreement between both tests&#44; we compared the data to determine the risk of CS-PCa obtained by the SelectMDx&#174; test and that obtained with the ERSPC calculator&#46; Finally&#44; we collected the additional tests and subsequent treatments received based on the previously described group&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0040" class="elsevierStylePara elsevierViewall">The SelectMDx&#174; test was performed on a total of 51 patients&#44; of whom 3 cases were excluded for being under 5-alpha reductase inhibitors treatment&#46; Patients baseline characteristics are described in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46; The techniques for the performance of the biopsy in the 14 patients &#40;29&#37;&#41; who had at least one previous negative PB were as follows&#58; systematic transrectal &#40;6 patients&#41;&#44; cognitive transrectal &#40;2 patients&#41; and transperineal fusion &#40;6 patients&#41;&#46; For the review of the results&#44; patients will be classified into groups based on the history of PB and mpMRI &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Patients with a previous negative biopsy and negative or doubtful mpMRI &#40;group a&#41;</span><p id="par0045" class="elsevierStylePara elsevierViewall">Fourteen patients &#40;29&#37;&#41; had at least one previous negative PB&#44; of which 12 had one mpMRI&#59; in 9 cases the results were normal or presented PIRADS&#8239;&#8804;&#8239;3 lesions&#46; In other words&#44; a total of 9 patients belong to this group &#40;the remaining patients with a previous negative biopsy are analyzed in the paragraphs corresponding to groups <span class="elsevierStyleItalic">b</span> y <span class="elsevierStyleItalic">c</span>&#41;&#46; In this group of patients&#44; the test showed a very low risk of CS-PCa in 7&#47;9 cases&#59; the 2 cases of greatest risk had a pathological rectal examination&#46; A transperineal fusion biopsy was performed in one of these 2 patients&#44; showing a result of atypical microacinar proliferation&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Patients with previous negative biopsy and suspicious mpMRI &#40;group b&#41;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Of the 3 patients who presented a PIRADS&#8239;4 lesions in the mpMRI&#44; one of them showed a very low risk of PCa and the other 2 presented a PCa probability of 58&#37; and 68&#37; and Gleason&#8239;&#8805;&#8239;7 in 30&#37; and 39&#37;&#44; respectively&#46; MpMRI was repeated to the patient with low-risk&#44; and his lesion was restaged to PIRADS&#8239;2&#46; One of the patients underwent a second biopsy in our center and was diagnosed with Gleason 3&#8239;&#43;&#8239;4 PCa and treated with radiotherapy and androgen blockade&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Patients with previous negative biopsy without mpMRI &#40;group c&#41;</span><p id="par0055" class="elsevierStylePara elsevierViewall">One of these two patients obtained <span class="elsevierStyleItalic">&#34;very low risk of PCa&#34;</span>&#44; and the other patient had 35&#37; for PCa and 11&#37; for CS-PCa&#46; This patient had a pathological digital rectal examination&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Patients without previous biopsy with negative or doubtful mpMRI &#40;group d&#41;</span><p id="par0060" class="elsevierStylePara elsevierViewall">This group includes 18 patients&#59; twelve presented a test result of <span class="elsevierStyleItalic">&#171;very low risk of PCa&#187;</span> and in the other 6 cases&#44; the probability of PCa ranged between 35 and 44&#37;&#44; and the probability of CS-PCa between 11 and 18&#37;&#46; Two of the patients with &#62;2&#37; risk underwent&#47;received a prostate biopsy in our center&#58; one detected a Gleason 3&#8239;&#43;&#8239;3 PCa and the other one a Gleason 3&#8239;&#43;&#8239;4 PCa&#44; which were treated with focal therapy &#40;irreversible electroporation&#41; and radical prostatectomy&#44; respectively&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Patients without a previous biopsy with suspicious mpMRI &#40;group e&#41;</span><p id="par0065" class="elsevierStylePara elsevierViewall">Only 2 patients presented PIRADS&#8239;4 lesions&#44; with a result of <span class="elsevierStyleItalic">&#171;very low risk of PC&#187;</span> in one of the 2 cases&#46; It should be noted that the case with a higher risk presented a positive digital rectal examination&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Patients without previous biopsy or mpMRI &#40;group f&#41;</span><p id="par0070" class="elsevierStylePara elsevierViewall">Of the 14 patients in this group&#44; 9 patients presented a <span class="elsevierStyleItalic">&#171;very low risk of PC&#187;</span> result&#44; and the remaining 5 patients obtained a probability of 43&#37;&#8211;92&#37; for PCa and 17&#37;&#8211;68&#37; for CS-PCa&#46; Two of these patients underwent a mpMRI after receiving the test&#44; showing PIRADS&#8239;2 and PIRADS&#8239;4 lesions with Gleason 3&#8239;&#43;&#8239;3 and Gleason 3&#8239;&#43;&#8239; lesions after biopsy&#44; respectively&#46; The latter was treated by radical prostatectomy&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Patients with positive digital rectal examination &#40;group g&#41;</span><p id="par0075" class="elsevierStylePara elsevierViewall">We must highlight that regardless of the other clinical-radiological parameters and having a previous biopsy&#44; the 12 patients who presented a pathological rectal examination showed a risk of CS-PCa&#8239;&#62;&#8239;2&#37; in the test&#44; with values of 35&#37;&#8211;92&#37; for PCa and 11&#37;&#8211;68&#37; for CS-PCa&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The comparison of the risk of PCa determined by the test and by the ERSPC calculator is shown in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#46; Only one of those patients who had a very low risk of presenting a CS-PCa in the test received a mpMRI after the test&#44; which turned out to be negative&#46; The remaining patients were followed up with PSA tests and did not require subsequent PBs&#46; The median follow-up of this cohort of patients after the performance of the test is 15&#46;1 months&#46; To date&#44; we have no suspicion or evidence of the appearance of CS-PCa in any of these patients&#46;</p></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Discussion</span><p id="par0085" class="elsevierStylePara elsevierViewall">The development of new molecular tests&#44; together with the implementation of mpMRI&#44; represent a change in the diagnostic approach of patients with suspected PCa&#46; Until the appearance of these tests&#44; the decision to perform a PB was based on the PSA levels and their derived calculations &#40;free PSA&#47;total PSA ratio&#44; PSA density&#44; PSA doubling time&#41; and digital rectal examination&#46; The first biomarker available for the diagnosis of PCa was Progensa PCA3&#44;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> followed by the &#34;Prostate Health Index score&#34; &#40;PHI-score&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> These first molecular tests are mainly based on the biomarker analyzed and globally predict the probability of detecting PCa&#46; Subsequently&#44; new molecular tests such as the 4&#8239;K score&#44;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> Select-MDx&#174;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> or MiPS<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> have emerged on the market&#44; which have two main advantages over their predecessors&#58; 1&#41; the combination of clinical parameters together with the evaluation of the biomarker that give a more accurate result&#59; 2&#41; they do not only predict the probability of finding any PCa on biopsy&#44; they also predict whether this tumor is CS-PCa&#46; Implementing the use of these tests into routine clinical practice allows us to expand the possibilities of determining which patients will really benefit from PB&#46; This is essential to avoid unnecessary biopsies&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">SelectMDx&#174; is a minimally invasive test&#44; which has shown to reliably detect those patients with a very low risk of CS-PCa&#46; The test has a negative predictive value of 98&#37;&#44; with a probability of not detecting a CS-PCa of only 2&#37; and achieving a biopsy avoidance rate of 53&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> These data are comparatively better than the rest of the biomarkers available on the market &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">With the clear objective of studying the usefulness and applicability of the test in real clinical practice&#44; instead of its sensitivity&#44; and given the heterogeneity of the use of the test&#44; the extrapolation of results in a small sample such as ours is limited&#46; However&#44; based on the groups with the largest number of patients&#44; we consider that the following are interesting observations&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">none-</span><p id="par0100" class="elsevierStylePara elsevierViewall">In group <span class="elsevierStyleItalic">a&#41;</span>&#44; the test showed a very low risk in 7 cases&#44; so the corresponding biopsies were avoided&#46; The test presented a higher result in two cases only&#44; and the biopsy of one of them showed atypical microacinar proliferation&#46; Despite the limited follow-up time&#44; we believe that the test is reliable in this patient profile&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">none-</span><p id="par0105" class="elsevierStylePara elsevierViewall">Group <span class="elsevierStyleItalic">d&#41;</span> was the largest of the sample &#40;18 patients&#41;&#44; with 12 patients with a very low risk of PCa&#46; PCa was detected in 2 of the 6 patients with a higher risk&#59; one was CS-PCa&#46; Although the sample is not high&#44; we do believe that in this clinical setting&#44; the test can provide useful information in the management of these patients&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">none-</span><p id="par0110" class="elsevierStylePara elsevierViewall">Of the 14 patients in group <span class="elsevierStyleItalic">f&#41;</span>&#44; the test showed a result of risk &#62;2&#37; in 5 patients&#44; and 2 of them were diagnosed with PCa&#46; Even if this indication is not included in the guidelines&#44; it is interesting to note that the test can also be useful in these patients&#44; for example in settings where mpMRI is not available&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">none-</span><p id="par0115" class="elsevierStylePara elsevierViewall">The number of patients included in the remaining groups &#40;<span class="elsevierStyleItalic">b&#44; c</span> and <span class="elsevierStyleItalic">e</span>&#41; is too small for drawing conclusions&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">none-</span><p id="par0120" class="elsevierStylePara elsevierViewall">We must highlight that the test showed a risk of suffering PCa&#8239;&#62;&#8239;2&#37; in the 12 patients who presented a pathological rectal examination&#46; Data regarding the impact of digital rectal examination on the test are scarce&#46; Trooskens et al&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> carried out a study that calculated sensitivity&#44; specificity and negative predictive value when one or more of the clinical parameters collected in the test were missing&#44; including digital rectal examination&#46; They conclude that despite excluding one or more variables&#44; the sensitivity and negative predictive value of the test do not decrease&#44; but its specificity does decrease&#46;</p></li></ul></p><p id="par0125" class="elsevierStylePara elsevierViewall">MpMRI is an imaging test with high sensitivity and a negative predictive value for PCa detection&#46;<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">24&#44;25</span></a> However&#44; even though the use of this test is increasingly widespread&#44; the interobserver variability remains high and around 15&#37; of CS-PCa are not detected by this test&#46; The use of molecular tests together with mpMRI provides an interesting additional diagnostic value in the management of these patients and can detect cases of CS-PCa that are not detected by imaging&#46; Studies like the one of Hendriks et al&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a> show the correlation between the results of the mpMRI and SelectMDx&#174;&#44; and the result of SelectMDx&#174; was significantly higher in patients with PIRADS&#8239;4&#8211;5 lesions&#46; In addition&#44; this study shows how the sensitivity and specificity of the combination of SelectMDx&#174; and mpMRI is greater than the combination of the imaging test with PSA or PCA3&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">This study presents a series of limitations to take into account&#58; 1&#41; short follow-up time to confirm that patients with a negative result are not subsequently diagnosed with PCa&#59; 2&#41; loss of follow-up in some patients&#59; 3&#41; the cost&#47;price of the test can generate selection bias&#46; SelectMDx&#174; test is currently not funded&#44; therefore it implies a direct cost to the patient&#46; However&#44; published studies have demonstrated the cost-effectiveness of the test in several European countries&#44; including Spain&#44; with a gain in quality-adjusted life years &#40;QALY&#41; of 0&#46;020 and savings of 247&#8239;&#1108; per patient&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">27</span></a></p><p id="par0135" class="elsevierStylePara elsevierViewall">Another limiting factor of the study is not having a radiological and&#47;or histological verification to corroborate the test in most cases&#46; However&#44; these studies have been previously carried out&#44;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11&#44;28</span></a> and it was not the objective of our work&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">This study represents the first study on the use of SelectMDx&#174; implemented into the usual clinical practice of a center in our setting&#44; with a sufficient number of patients to draw initial conclusions&#46; Based on our results&#44; we believe that the two main scenarios in which the use of SelectMDx&#174; is contemplated would be those patients with suspected PCa&#44; without a biopsy or with a history of negative PB&#44; with normal or doubtful mpMRI &#40;PIRADS&#8239;&#8804;&#8239;3&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Conclusion</span><p id="par0145" class="elsevierStylePara elsevierViewall">SelectMDx&#174; is a promising test for the detection of very low risk of CS-PCa&#46; Its use in routine clinical practice is a very convenient tool&#44; especially in patients with suspected PCa with or without previous negative biopsies&#44; in which the mpMRI shows a normal or doubtful result&#46; The presence of a pathological digital rectal examination can condition the test result&#44; with an overestimation of PCa risk&#46; These results must be validated by further studies with a larger sample&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Conflicts of interest</span><p id="par0150" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest&#46;</p></span></span>"
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              "titulo" => "Patients with a previous negative biopsy and negative or doubtful mpMRI &#40;group a&#41;"
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              "titulo" => "Patients with previous negative biopsy and suspicious mpMRI &#40;group b&#41;"
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              "titulo" => "Patients with previous negative biopsy without mpMRI &#40;group c&#41;"
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              "titulo" => "Patients without previous biopsy with negative or doubtful mpMRI &#40;group d&#41;"
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              "titulo" => "Patients without a previous biopsy with suspicious mpMRI &#40;group e&#41;"
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              "titulo" => "Patients without previous biopsy or mpMRI &#40;group f&#41;"
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              "titulo" => "Patients with positive digital rectal examination &#40;group g&#41;"
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          "titulo" => "Discussion"
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    "fechaRecibido" => "2019-09-15"
    "fechaAceptado" => "2020-03-22"
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          "clase" => "keyword"
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            0 => "Prostate cancer"
            1 => "Diagnosis"
            2 => "Biomarker"
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        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Palabras clave"
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          "palabras" => array:3 [
            0 => "C&#225;ncer de pr&#243;stata"
            1 => "Diagn&#243;stico"
            2 => "Marcador"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">The use of biomarkers in the detection of prostate cancer &#40;PC&#41; can decrease overdiagnosis and overtreatment of non-significant PC&#46; We analyze the usefulness and applicability of the SelectMDx&#174; marker in a routine clinical practice setting&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Material and methods</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Retrospective study of 48 patients evaluated by the SelectMDx&#174; test between July 2017 and April 2019&#46; Patients were stratified into two groups according to the risk estimated by the clinically significant CP test &#40;CS-PC&#41;&#58; &#60;2&#37; or &#34;very low risk&#34;&#44; and &#62;2&#37;&#46; Results were expressed based on previous prostate biopsy &#40;PB&#41; and MRI outcomes&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Patients with negative PB and normal&#47;doubtful MRI had &#60;2&#37; risk in 7&#47;9 cases&#46; Patients without PB and normal&#47;doubtful MRI had &#60;2&#37; risk in 12&#47;18 cases&#44; and 2&#47;6 cases with a &#62;2&#37; risk presented CS-PC&#46; Of the 14 patients with no previous PB or MRI&#44; 9 had &#60;2&#37; risk&#44; and 2 cases were diagnosed with PC from the group of patients &#40;5&#41; with risk &#62;2&#37;&#46; The number of patients in the remaining subgroups is too small to draw any conclusions&#46; In all cases with pathological digital rectal examination&#44; the test showed a &#62;2&#37; PC risk&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">SelectMDx&#174; is a promising test for detecting patients with a very low risk of CS-PC&#44; especially in patients with suspected PC&#44; with or without negative PB&#44; with normal&#47;doubtful MRI&#46; The presence of a pathological digital rectal examination may condition the result of the test&#46;</p></span>"
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          0 => array:2 [
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            "titulo" => "Introduction"
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            "titulo" => "Material and methods"
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          2 => array:2 [
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducci&#243;n</span><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">El uso de biomarcadores en la detecci&#243;n del c&#225;ncer de pr&#243;stata &#40;CP&#41; puede disminuir el sobrediagn&#243;stico y sobretratamiento de CP no significativos&#46; Analizamos la utilidad y aplicabilidad del marcador SelectMDx&#174; en un entorno de pr&#225;ctica cl&#237;nica habitual&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Material y m&#233;todos</span><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">Estudio retrospectivo de 48 pacientes evaluados mediante el test SelectMDx&#174; entre julio de 2017 y abril de 2019&#46; Los pacientes se estratificaron en dos grupos seg&#250;n el riesgo estimado por el test de CP cl&#237;nicamente significativo &#40;CP-CS&#41;&#58; &#60;2&#37; o &#8220;muy bajo riesgo&#8221;&#44; y &#62;2&#37;&#46; Los resultados se expresaron en funci&#243;n de los antecedentes de biopsia prost&#225;tica &#40;BP&#41; y RMmp&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">En pacientes con BP negativa y RMmp normal&#47;dudosa el riesgo fue &#60;2&#37; en 7&#47;9 casos&#46; En pacientes sin BP y RMmp normal&#47;dudosa el riesgo fue &#60;2&#37; en 12&#47;18 casos&#44; y 2&#47;6 casos con un riesgo &#62;2&#37; presentaron un CP-CS&#46; De los 14 pacientes sin BP ni RMmp previas&#44; 9 presentaron un riesgo &#60;2&#37;&#44; con 2 casos diagnosticados de CP en los 5 pacientes con riesgo &#62;2&#37;&#46; En el resto de subgrupos el n&#250;mero de pacientes es peque&#241;o como para poder extraer conclusiones&#46; En todos los casos con tacto rectal patol&#243;gico el test demostraba un riesgo de padecer CP&#8239;&#62;&#8239;2&#37;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusi&#243;n</span><p id="spar0095" class="elsevierStyleSimplePara elsevierViewall">SelectMDx&#174; es un test prometedor para detectar pacientes con un riesgo muy bajo de CP-CS&#44; especialmente en pacientes con sospecha de CP con o sin BP negativas&#44; en los que la RMmp muestre un resultado normal&#47;dudoso&#46; La presencia de un tacto rectal patol&#243;gico puede condicionar el resultado del test&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Quintana LM&#44; Fern&#225;ndez Pascual E&#44; Linares Espin&#243;s E&#44; Martinez-Ballesteros C&#44; Martin-Vivas C&#44; Rengifo Abbad D&#44; et al&#46; Experiencia inicial del uso de SelectMDx&#174; en el diagn&#243;stico de c&#225;ncer de pr&#243;stata en un entorno de pr&#225;ctica cl&#237;nica habitual &#171;real-world evidence&#187;&#46; Actas Urol Esp&#46; 2020&#59;44&#58;400&#8211;407&#46;</p>"
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The patients selected to undergo the test receive a prostate massage prior to obtaining the urine sample&#46; The combination of biomarkers and described clinical data predicts the probability of clinically significant prostate cancer and prostate cancer&#46;</p> <p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">PCa&#58; prostate cancer&#59; PSA&#58; prostate specific antigen&#59; mpMRI&#58; multiparametric magnetic resonance imaging&#46;</p>"
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          "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Algorithm for use proposed for the implementation of SelectMDx&#174; in routine clinical practice&#46;</p> <p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">PCa&#58; prostate cancer&#59; PSA&#58; prostate specific antigen&#59; mpMRI&#58; multiparametric magnetic resonance imaging&#46;</p>"
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          "leyenda" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Data on age&#44; PSA&#44; prostate volume&#44; and PSA density are expressed as medians &#40;interquartile range&#41;&#46;</p><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">PCa&#58; prostate cancer&#59; PSA&#58; prostate specific antigen&#59; mpMRI&#58; multiparametric magnetic resonance imaging&#46;</p>"
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">17&#37; &#40;8&#47;48&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">PSA&#44; ng&#47;mL&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6&#44;5 &#40;5&#8722;15&#44;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Prostate volume&#44; cm<span class="elsevierStyleSup">3</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">60 &#40;45&#8722;78&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">PSA density&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;11 &#40;0&#44;08&#8211;0&#44;16&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Pathological rectal examination&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">25&#37; &#40;12&#47;48&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Previous negative biopsy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">29&#37; &#40;14&#47;48&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Previous mpMRI&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">65&#37; &#40;31&#47;48&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">PIRADS&#8239;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">5&#47;31&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">PIRADS&#8239;&#8804;&#8239;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">26&#47;31&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
              ]
              "imagenFichero" => array:1 [
                0 => "xTab2367619.png"
              ]
            ]
          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Baseline characteristics of the patients in the sample&#46;</p>"
        ]
      ]
      3 => array:8 [
        "identificador" => "tbl0010"
        "etiqueta" => "Table 2"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0020"
            "detalle" => "Table "
            "rol" => "short"
          ]
        ]
        "tabla" => array:2 [
          "leyenda" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">mpMRI&#58; multiparametric magnetic resonance imaging&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Clinical scenario&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">SelectMDx&#174; risk &#8804;&#8239;2&#37;&#47;&#62;&#8239;2&#37; &#40;total&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">ERSPC calculator biopsy indication No&#47;Yes &#40;total&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Data agreement &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Negative biopsy - mpMRI PIRADS&#8239;&#8804;&#8239;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">7 &#47; 2 &#40;9&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">5 &#47; 3 &#40;8&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">7 &#47; 8 &#40;87&#44;5&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Negative biopsy - mpMRI PIRADS&#8239;&#8805;&#8239;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 &#47; 2 &#40;3&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0 &#47; 2 &#40;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 &#47; 2 &#40;50&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Negative biopsy - No mpMRI&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 &#47; 1 &#40;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 &#47; 1 &#40;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2 &#47; 2 &#40;100&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">No biopsy - mpMRI PIRADS&#8239;&#8804;&#8239;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12 &#47; 6 &#40;18&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">14 &#47; 1 &#40;15&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">11 &#47; 15 &#40;73&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">No biopsy - mpMRI PIRADS&#8239;&#8805;&#8239;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 &#47; 1 &#40;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 &#47; 1 &#40;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2 &#47; 2 &#40;100&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">No biopsy - No mpMRI&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9 &#47; 5 &#40;14&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3 &#47; 3 &#40;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6 &#47; 6 &#40;100&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Pathological rectal examination&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0 &#47; 12 &#40;12&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2 &#47; 8 &#40;10&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8 &#47; 10 &#40;80&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Total&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">48&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">38&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">31 &#47; 38 &#40;82&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
              ]
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                0 => "xTab2367620.png"
              ]
            ]
          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Stratified results according to diagnostic process and risk percentage&#46;</p>"
        ]
      ]
      4 => array:8 [
        "identificador" => "tbl0015"
        "etiqueta" => "Table 3"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0025"
            "detalle" => "Table "
            "rol" => "short"
          ]
        ]
        "tabla" => array:2 [
          "leyenda" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">AUC&#58; area under the curve&#59; CS-PCa&#58; clinically significant prostate cancer&#59; fPSA&#58; free PSA&#59; tPSA&#58; total PSA&#59; NPV&#58; negative predictive value&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Test&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Biomarker&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Sample&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Diagnostic accuracy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Progensa PCA3<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">9&#44;16&#8211;18</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">PCA3 and PSA mRNA&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Urine&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">NPV&#58; 88&#37;&#8722;90&#37;&#59; AUC&#58; 0&#46;66&#8722;0&#46;69&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Risk of not detecting CS-PCa&#58; 10&#37;&#8722;12&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Avoids 44&#37; biopsies&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">PHI score<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#44;19&#44;20</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">tPSA&#44; PSAl&#44; p2PSA&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Blood&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">NPV&#58; 67&#37;&#8722;92&#37;&#59; AUC&#58; 0&#46;7&#8722;0&#46;77&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Risk of not detecting CS-PCa&#58; 8&#37;&#8722;33&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Avoids 36&#37; biopsies&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&#8239;K score<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">tPSA&#44; fPSA&#44; intact PSA&#44; hK2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Blood&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">VPN&#58; 95&#37;&#59; AUC&#58; 0&#46;82&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Risk of not detecting CS-PCa&#58; 5&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Avoids 36&#37; biopsies&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">MiPS<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">tPSA&#44; PCA3 mRNA&#44; and TMPRSS2-ERG&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Urine&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">AUC&#58; 0&#44;77&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">No data available on the other variables&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">SelectMDx<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">HOXC6 and DLX1 mRNA&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Urine&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">VPN&#58; 98&#37;&#59; AUC&#58; 0&#46;86&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Risk of not detecting CS-PCa&#58; 2&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Avoids 53&#37; biopsies&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">ConfirmMDx<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">GSTP1&#44; APC and RASSF gene methylation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Prostate biopsy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">NPV&#58; 96&#37;&#59; AUC&#58; 0&#46;74&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Risk of not detecting CS-PCa&#58; 4&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">ExoDx<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">PCA3&#44; ERG and SPDEF mRNA&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Urine&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">NPV&#58; 91&#37;&#59; AUC&#58; 0&#46;73&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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