Correlation of mRNA-PCA3 urine levels with the new grading system in prostate cancer

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"aff0025" ] ] ] ] "afiliaciones" => array:5 [ 0 => array:3 [ "entidad" => "BIOPAT, Biopatologia Molecular SL, Grup Assistència, Barcelona, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "HISTOPAT Laboratoris, Barcelona, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Department of Statistics, Faculty of Biology, Universitat de Barcelona, Barcelona, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "ICUN, Institut Català d’Urologia i Nefrologia, Barcelona, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Hospital de Barcelona, SCIAS, Grup Assistència, Barcelona, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Correlación de mRNA-PCA3 en orina con el nuevo sistema de gradación de cáncer de próstata" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 866 "Ancho" => 1498 "Tamanyo" => 44150 ] ] "descripcion" => array:1 [ "en" => "Distribution of the Gleason score according to the PCA3 score (s-PCA3) in patients with a diagnosis of PCa (n=85)." ] ] ] "textoCompleto" => "IntroductionProstate cancer (PCa) is the second most common cancer and the fifth leading cause of cancer death in men worldwide.<a class="elsevierStyleCrossRef" href="#bib0155">1</a> PCa has been described as a heterogeneous disease with varying clinical and morphological characteristics.<a class="elsevierStyleCrossRef" href="#bib0160">2</a> Traditionally, screening has been based on digital rectal examination (DRE) and measurement of serum prostate-specific antigen (PSA), which has a low specificity for PCa.<a class="elsevierStyleCrossRefs" href="#bib0165">3–6</a> The management of patients with altered PSA values not exceeding 10ng/ml, known as the PSA gray zone, is especially challenging because 75% of such patients have negative biopsies; the raised PSA being due to, for example, prostate enlargement, prostatitis, or benign prostatic hyperplasia (BPH).<a class="elsevierStyleCrossRef" href="#bib0170">4</a> Moreover, the clinical significance of many diagnosed low-grade PCa is questionable and a challenging issue in the current management of PCa. New clinical assays are accordingly required to reduce over-detection and improve early detection of significant tumors.<a class="elsevierStyleCrossRef" href="#bib0180">6</a> A diagnostic tool capable of distinguishing patients with clinically significant cancer who need curative treatment from those with indolent cancer who would benefit from active surveillance is urgently needed.The PCA3 (Prostate Cancer 3 gene) noncoding mRNA is a molecular biomarker with high specificity for PCa that can be determined in urine of patients with suspected PCa. It represents an additional diagnostic test that reduces the indications for biopsy and improves its efficiency.<a class="elsevierStyleCrossRef" href="#bib0185">7</a> Moreover, PCA3 could help to avoid over-detection of clinically insignificant PCa while not missing clinically significant cancer as it has been associated with characteristics indicative of tumor aggressiveness such as tumor volume, tumor grade, and Gleason score.<a class="elsevierStyleCrossRefs" href="#bib0190">8–10</a> Used in conjunction with established imaging modalities and serological and clinical data, PCA3 may also be a useful marker to improve the selection of patients suitable for active surveillance or focal therapy.The purpose of this study was to evaluate the yield of PCA3 as an additional test in the management of patients with suspected PCa and to investigate whether our previously published results, in a prospective study of 598 patients, would be confirmed.<a class="elsevierStyleCrossRef" href="#bib0205">11</a> Moreover, the association of PCA3 with the new Grade Groups proposed by the International Society of Urological Pathology (ISUP) in 2014 was evaluated.<a class="elsevierStyleCrossRefs" href="#bib0210">12–14</a>Patients and methodsThis retrospective study included data from consecutive patients with suspected PCa and candidates for prostate biopsy who attended the urology department between November 2009 and April 2016. A protocol for the study, including inclusion and exclusion criteria, and a copy of the informed consent form to be signed by patients were approved by the Ethics Committee of our institution.Samples and patientsA total of 1038 urine samples collected after prostate massage were studied in our laboratory within the period stated above. For inclusion in this study, sample collection had to be indicated by one of the following: elevated PSA and prior negative biopsy, altered PSA but lower than 10ng/ml without prior biopsy, altered PSA and presence of a well-known prostatic inflammatory disease (prostatitis or BPH), or high PSA level in the presence of a comorbidity giving rise to an increased biopsy-associated risk. Samples corresponding to patients with previous PCa diagnoses (71) were excluded.A total of 967 urine samples corresponding to 814 patients were included; 132 patients had more than one sample studied during their clinical follow-up. When comparative statistical analysis with other clinical variables (age, serum PSA, presence of prostatitis, and prostate volume) was performed, only the latest study data were used, resulting in the exclusion of 153 urine samples. Data recorded included: age, total PSA (ng/ml) and prostate volume (cc) of all patients. When a biopsy was performed, the number of cylinders obtained was recorded and when a PCa was diagnosed, the number of affected cylinders, the percentage of tumor, the Gleason score, and the Grade Group were also recorded. In cases diagnosed as PCa before publication of the Gleason Grade Group guidelines, the Gleason score was converted to its corresponding Grade Group according to published instructions.<a class="elsevierStyleCrossRefs" href="#bib0210">12–14</a>PCA3 determinationThe first voided urine after DRE with prostatic massage consisting in three palpations per lobe was collected and tested with the Progensa™ PCA3 Assay kit (GenProbe) following the manufacturer's instructions. The kit quantifies PCA3 and PSA mRNA molecules and generates a PCA3 score (s-PCA3) according to the formula: (PCA3 mRNA/PSA mRNA)×1000. The s-PCA3 was considered positive when it was 35 or higher, and only in these cases was a prostate biopsy recommended owing to the high probability of detecting PCa.<a class="elsevierStyleCrossRef" href="#bib0225">15</a> However, the final decision whether or not to perform a biopsy was the responsibility of the patient's physician. When the association between PCA3 and the parameters of tumor aggressiveness was analyzed, the s-PCA3 cut-off was established at 50, in accordance with previous studies.<a class="elsevierStyleCrossRefs" href="#bib0205">11,16,17</a>Prostate biopsy protocolTransrectal ultrasound-guided prostate biopsies were performed in an operating room with patients under anesthesia with sedation. A minimum of five cylinders per lobe were obtained, with additional cores when suspicious nodules were detected by DRE or ultrasound. In those patients who had a previous negative biopsy, a minimum of ten cylinders per lobe were obtained.Histopathological studyTwo pathologists performed the histopathological study on serial sections of formalin-fixed paraffin-embedded tissue stained with hematoxylin–eosin. Immunohistochemical study with Alpha Ethylacyl-CoA-Racemase (AMACR) and basal cell markers (p63 and 34βE12 cytokeratins) was performed when requested by the pathologist. The diagnostic entities covered were: prostate adenocarcinoma (PCa), atypical small acinar proliferation (ASAP), high-grade prostatic intraepithelial neoplasia (HGPIN), chronic prostatitis, other non-neoplastic processes, and normality. In PCa cases the grade was determined based on the Gleason patterns <a class="elsevierStyleCrossRef" href="#bib0240">18</a>and the Grade Group.<a class="elsevierStyleCrossRefs" href="#bib0210">12–14</a> The new ISUP grading system for prostatic adenocarcinoma classifies PCa into five prognostically distinct Grade Groups (1–5).<a class="elsevierStyleCrossRef" href="#bib0210">12</a> This classification reflects prostate cancer biology more accurately than the Gleason score. The Grade Group 1 comprises patients with Gleason (3+3) PCa, mostly with an excellent prognosis and no potential lymph node involvement; such patients are suitable for active surveillance although other clinical information must be considered for optimum treatment.<a class="elsevierStyleCrossRef" href="#bib0245">19</a>The ASAP category was reserved for microglandular proliferations that displayed morphological and immunohistochemical characteristics suspicious for PCa (loss of basal layer and/or expression of AMACR) but were insufficiently represented in biopsies to support a definitive diagnosis of PCa.In cases diagnosed as PCa, the presence of tumor in more than 33% of the cylinders was considered an indicator of tumor stage.Statistical analysisHypothetical associations between pairs of variables were analyzed using Fisher's exact test for the categorical variables and linear regression analysis for the continuous variables. To determine the association between a shortlist of three categorical variables, the best log-linear model was established using the stepwise algorithm and the Akaike information criterion starting from the full model, i.e. with all possible interactions among the three variables.<a class="elsevierStyleCrossRef" href="#bib0250">20</a> In order to investigate whether s-PCA3 could predict the Grade Group, a logistic model was applied.<a class="elsevierStyleCrossRef" href="#bib0255">21</a> All statistical analyses were performed with the R software.<a class="elsevierStyleCrossRef" href="#bib0260">22</a>ResultsA total of 967 urine samples corresponding to 814 patients with a mean age of 65.8 years (SD 8.1 years) were included. Most of the s-PCA3 tests (91.7%) were performed in patients with elevated PSA and a negative previous biopsy or alterations in PSA levels not exceeding 10ng/ml (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). A valid result was obtained in 98.5% of samples. The mean s-PCA3 value was 48.7. Details of the numeric variables analyzed are reported in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>. The s-PCA3 showed a very weak significant relationship with age (p<0.05, with 5.4% of the variability explained by the s-PCA3) and no significant relation with serum PSA level (p=0.798), presence of prostatitis (p=0.826), or prostate volume (p=0.130). 522 samples corresponding to 431 patients had a negative s-PCA3. In these cases, accounting for 54% of the samples and 52.9% of patients, no biopsy was recommended; however, 37 of these patients did undergo a biopsy following their urologists’ criteria. 24 (5.6%) patients had a negative biopsy, of whom two (0.5%) were diagnosed with HGPIN, one (0.2%) with ASAP, and 10 (2.3%) with PCa (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>). The rest of the patients with a negative s-PCA3 were managed by their urologists.<elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="tbl0015"></elsevierMultimedia>In patients with samples that had a positive s-PCA3 (44.5%), a subsequent biopsy was recommended. Of the 151 biopsies studied, 56.3% yielded a diagnosis of PCa, 4.6% ASAP, and 6% HGPIN, while 33.1% showed no evidence of malignancy (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>). When the s-PCA3 cut-off was set to 50 instead of 35, the percentage of PCa increased to 59.5% and the percentage of biopsies with no evidence of malignancy decreased to 30.2%, while the percentages of ASAP and HGPIN did not change significantly. The probability of a positive biopsy increased as the s-PCA3 increased (p=0.041). The percentage of cylinders with carcinoma detected in the biopsy was assessed in 75 of the 85 cases with a diagnosis of PCa; the 10 remaining cases were surgical resection specimens. The percentage of affected cylinders increased as the s-PCA3 increased, the relationship being statistically significant (p=0.015). In no patient with a diagnosis of PCa and an s-PCA3 between 35 and 50 no more than 33% of cylinders were affected (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). The s-PCA3 and the Gleason score showed a statistically significant relationship (p=0.001). Of those cases with an s-PCA3 greater than 50, 76.8% had a Gleason score≥7 (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>). The best log-linear model, including s-PCA3, the Gleason score, and the percentage of affected cylinders, retained in the final equation the interactions between s-PCA3 and percentage of affected cylinders (p=0.002) and between s-PCA3 and the Gleason score (p<0.000), confirming the relationship shown previously with Fisher's exact test.<elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia>Only one patient in this series was in Grade Group 5. For the purpose of all statistical analyses, this patient was grouped with those in Grade Group 4. A statistically significant relationship was observed between s-PCA3 and the Grade Group (p=0.008). Of PCa patients with a positive s-PCA3 lower than 50, 68.8% were in Grade Group 1 (<a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a>). The best log-linear model, including s-PCA3, the Grade Group, and the percentage of affected cylinders, retained in the final equation the interactions between s-PCA3 and percentage of affected cylinders (p=0.002) and between s-PCA3 and the Grade Group (p=0.003), confirming the relationship shown previously with Fisher's exact test (<a class="elsevierStyleCrossRef" href="#fig0020">Fig. 4</a>). A logistic model was employed to test whether s-PCA3 and the percentage of affected cylinders could predict the Grade Group. A statistically significant relationship between the three variables was confirmed, as was shown previously by Fisher's exact test and the log-linear model. At a cut-off point of 0.625, the sensitivity and specificity of the model were 79% and 64% respectively; the positive predictive value was 84% and the negative predictive value was 56%.<elsevierMultimedia ident="fig0015"></elsevierMultimedia><elsevierMultimedia ident="fig0020"></elsevierMultimedia>DiscussionIn this series the s-PCA3 was not related to PSA level, prostate volume, or presence of prostatitis, in agreement with data published in previous studies<a class="elsevierStyleCrossRefs" href="#bib0265">23–25</a>; moreover, only a very weak significant relationship was found with patient age. Incorporation of the PCA3 study into PCa screening significantly reduced (by 54%) the indication for biopsy, in accordance with previously published data.<a class="elsevierStyleCrossRefs" href="#bib0205">11,17,28,29</a> In patients with a positive s-PCA3, the percentage of positive biopsies was markedly increased (to 60.9%, including ASAP) compared with the percentage in biopsies indicated by PSA and DRE alone. There was a statistically significant relationship between s-PCA3 and the presence of PCa in the subsequent biopsy, as has been reported previously.<a class="elsevierStyleCrossRefs" href="#bib0230">16,25,26</a> The s-PCA3 was not able to predict the presence of PCa in ten patients in the series. This percentage of false negative results is in accordance with that reported by the PCA3 kit manufacturer. The relation between s-PCA3 and different parameters associated with tumor aggressiveness, such as Gleason score and the percentage of cylinders in which PCa was detected, was also analyzed. All of the latter parameters showed a statistically significant relationship with s-PCA3. None of the patients with a positive s-PCA3 below 50 showed more than 33% of cylinders affected by PCa and 68.8% of them had a Gleason score below 7. In contrast, 76.8% of patients with an s-PCA3 over 50 had a Gleason score higher than or equal to 7. These results are in agreement with previously published data from reviews and meta-analyses and also confirm our previous results.<a class="elsevierStyleCrossRefs" href="#bib0205">11,16,26,27</a> To our knowledge this is the first time that the relation between s-PCA3 and the new Grade Group has been explored. In this series there was a statistically significant relationship between s-PCA3 and the Grade Group. These results were confirmed in two log-linear models. The high prevalence of low Grade Group tumors in patients with PCa and a positive PCA3 lower than 50 may warrant recommendation of a conservative clinical attitude in this subgroup. A logistic model was designed in order to analyze whether s-PCA3 could predict the Grade Group in patients with PCa. This model once more confirmed a strong relationship between s-PCA3 and the Grade Group. However, its predictive capacity was weak, probably owing to the small size of the series, and more data are needed in order to confirm these preliminary results. In our series, 68.6% of PCa with a positive s-PCA3 below 50 were in Grade Group 1, indicating that subsequent biopsy could be avoided or delayed in this patient subgroup, with a watchful waiting strategy instead being adopted unless contraindicated by other clinical information. In contrast, the 76.8% of patients in our series with an s-PCA3 higher than 50 were assigned to Grade Groups 2–5, suggesting that a more aggressive therapeutic approach may be adequate. Although some series<a class="elsevierStyleCrossRef" href="#bib0300">30</a> do not reach the same conclusion, when all the results are considered, in addition to the new evidence showing a significant relationship between s-PCA3 and the Grade Group, they confirm that s-PCA3 has prognostic significance in prediction of the aggressiveness of PCa, as suggested by previous studies.<a class="elsevierStyleCrossRefs" href="#bib0205">11,17,26,27</a>ConclusionsIn this retrospective study we reaffirmed our previously published results showing that s-PCA3 outperforms PSA in predicting biopsy diagnosis of PCa. Moreover, the prognostic significance of s-PCA3 was confirmed, as it was associated with parameters of tumor aggressiveness such as tumor volume and Gleason score. Importantly, to our knowledge this is the first time that an association has been demonstrated between s-PCA3 and the new Grade Group. In conclusion, s-PCA3 may serve as an additional marker to reduce the indication for biopsies and to avoid overdiagnosis and overtreatment of patients with suspected PCa. Moreover, insofar as it is predictive of the Grade Group and tumor extension, s-PCA3 can provide information of prognostic significance.Conflict of interestsThe authors declare no conflict of interest." "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres1130441" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Purpose" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Patients and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1063445" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1130442" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1063444" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Patients and methods" "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Samples and patients" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "PCA3 determination" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Prostate biopsy protocol" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Histopathological study" ] 4 => array:2 [ "identificador" => "sec0035" "titulo" => "Statistical analysis" ] ] ] 6 => array:2 [ "identificador" => "sec0040" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0045" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0050" "titulo" => "Conclusions" ] 9 => array:2 [ "identificador" => "sec0055" "titulo" => "Conflict of interests" ] 10 => array:2 [ "identificador" => "xack384835" "titulo" => "Acknowledgments" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2018-01-24" "fechaAceptado" => "2018-04-22" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1063445" "palabras" => array:5 [ 0 => "Gleason grade" 1 => "Prostate Grade Group" 2 => "PCA3" 3 => "PSA" 4 => "Screening" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1063444" "palabras" => array:5 [ 0 => "Grado de Gleason" 1 => "Grado grupo próstata" 2 => "PCA3" 3 => "PSA" 4 => "Screening" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "PurposeTo evaluate the PCA3 (Prostate Cancer 3 gene) as a tool to improve prostate cancer (PCa) screening and its capability to predict PCa aggressiveness. Patients and methodsA retrospective study with data from consecutive patients with suspected PCa seen in the urology department between November 2009 and April 2016 and who were candidates for prostate biopsy. A total of 1038 urine samples were tested in our laboratory with a kit that generated a PCA3 score (s-PCA3). A prostate biopsy was recommended only in those patients with s-PCA3≥35. Associations between variables were analyzed using the R software. ResultsIn patients with a positive s-PCA3 (44.5%), a subsequent biopsy was recommended. Of a total of 151 biopsies studied, 56.3% yielded a diagnosis of PCa. The probability of a positive biopsy increased as the s-PCA3 increased (p=0.041). The percentage of affected cylinders increased as the s-PCA3 increased (p=0.015). A statistically significant relationship was observed between s-PCA3 and both the Gleason score and the Grade Group (p=0.001 and 0.008, respectively). The best log-linear models and a logistic model confirmed the relationships shown previously with Fisher's exact tests. ConclusionsS-PCA3 may serve as an additional marker to reduce the indication for biopsies and avoid overdiagnosis and overtreatment of patients with suspected PCa. The prognostic significance of s-PCA3 was confirmed, as it was associated with tumor volume and Gleason score. Importantly, to our knowledge this is the first time that an association has been demonstrated between s-PCA3 and the new Grade Group." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Purpose" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Patients and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "ObjetivoEvaluar el estudio de PCA3 (gen Prostate Cancer 3) en orina como test complementario para mejorar el cribado de cáncer de próstata (CaP), así como su capacidad de predecir la agresividad tumoral antes de la biopsia. Pacientes y métodosEn este estudio retrospectivo se incluyeron pacientes consecutivos con sospecha de CaP y candidatos a biopsia, que se presentaron en la consulta del urólogo entre noviembre de 2009 y abril de 2016. Se testaron en nuestro laboratorio un total de 1.038 muestras de orina con un kit que generó un PCA3 score (s-PCA3). Se recomendó la biopsia en aquellos pacientes con s-PCA3≥35. Las asociaciones entre variables se analizaron con el software R. ResultadosEn los pacientes con s-PCA3 positivo (44,5%) se recomendó la realización de una biopsia. Se estudiaron un total de 151 biopsias de las que un 56,3% fueron diagnosticadas de CaP. La probabilidad de obtener una biopsia positiva aumentó a medida que lo hacia el s-PCA3 (p=0,041). El porcentaje de cilindros afectados aumentó a medida que lo hacía el s-PCA3 (p=0,015). El s-PCA3 presentó una relación estadísticamente significativa con el grado de Gleason (p=0,001) y el grado grupo (p=0,008). El mejor modelo Log-lineal, así como el modelo logístico confirmaron las relaciones observadas previamente con las pruebas exactas de Fisher. ConclusionesEl s-PCA3 es una herramienta complementaria que permite reducir la indicación de biopsias y evitar el sobrediagnóstico y sobretratamiento de pacientes con sospecha de CaP. La significación pronóstica del s-PCA3 fue confirmada al demostrarse su asociación con el volumen tumoral y el grado de Gleason. Según la información de la que disponemos, este es el primer estudio en el que se demuestra la asociación entre el s-PCA3 y el nuevo sistema de gradación del CaP." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "multimedia" => array:7 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 883 "Ancho" => 1503 "Tamanyo" => 51258 ] ] "descripcion" => array:1 [ "en" => "Percentage of affected cylinders in the biopsy in relation to the PCA3 score (s-PCA3) in patients with a diagnosis of PCa (n=75)." ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 866 "Ancho" => 1498 "Tamanyo" => 44150 ] ] "descripcion" => array:1 [ "en" => "Distribution of the Gleason score according to the PCA3 score (s-PCA3) in patients with a diagnosis of PCa (n=85)." ] ] 2 => array:7 [ "identificador" => "fig0015" "etiqueta" => "Figure 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 983 "Ancho" => 1570 "Tamanyo" => 56344 ] ] "descripcion" => array:1 [ "en" => "Distribution of the Grade Group according to the PCA3 score (s-PCA3) in patients with a diagnosis of PCa (n=85)." ] ] 3 => array:7 [ "identificador" => "fig0020" "etiqueta" => "Figure 4" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr4.jpeg" "Alto" => 1826 "Ancho" => 2321 "Tamanyo" => 145459 ] ] "descripcion" => array:1 [ "en" => "Bar chart of the log-linear model containing the PCA score (s-PCA3), the Grade Group, and the percentage of affected cylinders in the biopsy (n=74)." ] ] 4 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "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="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Indication for the s-PCA3 study \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">No. of samples (%) \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Negative prior biopsy \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">467 (48.3) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Elevated PSA≤10ng/ml \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">420 (43.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Risk factors for biopsy \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">30 (3.1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Known benign prostate pathology \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">27 (2.8) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">No specified indication \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">23 (2.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Total \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">967 (100) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1928686.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Indications for study of the PCA3 score (s-PCA3)." ] ] 5 => array:8 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at2" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "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="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Median (minimum–maximum) \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Total PSA (ng/ml) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">5.8 (0.5–134) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Prostate volume (cc) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">50 (2–200) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Percentage of affected cylinders \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">20 (1–100) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1928688.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Description of the variables studied." ] ] 6 => array:8 [ "identificador" => "tbl0015" "etiqueta" => "Table 3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at3" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "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="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">s-PCA3 \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Samples (%) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Patients (%) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " colspan="3" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">N° of patients with biopsy (%)</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">N° of patients within its s-PCA3 group (%) \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " rowspan="4" align="left" valign="top"><35</td><td class="td" title="table-entry " rowspan="4" align="char" valign="top">522 (54)</td><td class="td" title="table-entry " rowspan="4" align="char" valign="top">431 (52.9)</td><td class="td" title="table-entry " rowspan="4" align="char" valign="top">37</td><td class="td" title="table-entry " align="left" valign="top">Non pathologic \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">24/37 (64.9) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">24/431 (5.6) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">ASAP \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">1/37 (2.7) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">1/431 (0.2) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">HGPIN \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">2/37 (5.4) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">2/431 (0.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">PCa \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">10/37 (27) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">10/431 (2.3) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="7" align="left" valign="top"></td></tr><tr title="table-row"><td class="td" title="table-entry " rowspan="4" align="left" valign="top">≥35</td><td class="td" title="table-entry " rowspan="4" align="char" valign="top">430 (44.5)</td><td class="td" title="table-entry " rowspan="4" align="char" valign="top">379 (46.6)</td><td class="td" title="table-entry " rowspan="4" align="char" valign="top">151</td><td class="td" title="table-entry " align="left" valign="top">Non pathologic \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">50/151 (33.1) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">50/379 (13.2) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">ASAP \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">7/151 (4.6) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">7/379 (1.8) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">HGPIN \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">9/151 (6) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">9/379 (2.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">PCa \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">85/151 (56.3) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">85/379 (22.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="7" align="left" valign="top"></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">N.V. \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">15 (1.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">4 (0.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="7" align="left" valign="top"></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Total \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">967 (100) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">814 (100) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">188 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1928687.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Samples and patient data according to s-PCA3 and biopsy results from the complete series." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:30 [ 0 => array:3 [ "identificador" => "bib0155" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:3 [ "comentario" => "ISBN: 978-92-832-0429-9" "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "International Agency for Research on Cancer" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "World Cancer Report 2014" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:1 [ "fecha" => "2014" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0160" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Prostate cancer as a model system for genetic diversity in tumors" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "J.A. 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"vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/16998855/0000005200000001/v1_201812220626/S1699885518300382/v1_201812220626/en/main.assets" "Apartado" => array:4 [ "identificador" => "7944" "tipo" => "SECCION" "es" => array:2 [ "titulo" => "Originales" "idiomaDefecto" => true ] "idiomaDefecto" => "es" ] "PDF" => "https://static.elsevier.es/multimedia/16998855/0000005200000001/v1_201812220626/S1699885518300382/v1_201812220626/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1699885518300382?idApp=UINPBA00004N"]

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Correlation of mRNA-PCA3 urine levels with the new grading system in prostate cancer

Correlación de mRNA-PCA3 en orina con el nuevo sistema de gradación de cáncer de próstata

Natalia Rodona,

Autor para correspondencia

nrodon@biopat.es

Corresponding author.

, Isabel Triasa,b,e, Montse Verdúa,b, Miquel Calvoc, Josep Mª Banusd, Xavier Puiga,b,e

a BIOPAT, Biopatologia Molecular SL, Grup Assistència, Barcelona, Spain

b HISTOPAT Laboratoris, Barcelona, Spain

c Department of Statistics, Faculty of Biology, Universitat de Barcelona, Barcelona, Spain

d ICUN, Institut Català d’Urologia i Nefrologia, Barcelona, Spain

e Hospital de Barcelona, SCIAS, Grup Assistència, Barcelona, Spain

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        "titulo" => "Correlaci&#243;n de mRNA-PCA3 en orina con el nuevo sistema de gradaci&#243;n de c&#225;ncer de pr&#243;stata"
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          "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Distribution of the Gleason score according to the PCA3 score &#40;s-PCA3&#41; in patients with a diagnosis of PCa &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>85&#41;&#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">Prostate cancer &#40;PCa&#41; is the second most common cancer and the fifth leading cause of cancer death in men worldwide&#46;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">1</span></a> PCa has been described as a heterogeneous disease with varying clinical and morphological characteristics&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">2</span></a> Traditionally&#44; screening has been based on digital rectal examination &#40;DRE&#41; and measurement of serum prostate-specific antigen &#40;PSA&#41;&#44; which has a low specificity for PCa&#46;<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">3&#8211;6</span></a> The management of patients with altered PSA values not exceeding 10<span class="elsevierStyleHsp" style=""></span>ng&#47;ml&#44; known as the PSA gray zone&#44; is especially challenging because 75&#37; of such patients have negative biopsies&#59; the raised PSA being due to&#44; for example&#44; prostate enlargement&#44; prostatitis&#44; or benign prostatic hyperplasia &#40;BPH&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">4</span></a> Moreover&#44; the clinical significance of many diagnosed low-grade PCa is questionable and a challenging issue in the current management of PCa&#46; New clinical assays are accordingly required to reduce over-detection and improve early detection of significant tumors&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">6</span></a> A diagnostic tool capable of distinguishing patients with clinically significant cancer who need curative treatment from those with indolent cancer who would benefit from active surveillance is urgently needed&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The PCA3 &#40;Prostate Cancer 3 gene&#41; noncoding mRNA is a molecular biomarker with high specificity for PCa that can be determined in urine of patients with suspected PCa&#46; It represents an additional diagnostic test that reduces the indications for biopsy and improves its efficiency&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">7</span></a> Moreover&#44; PCA3 could help to avoid over-detection of clinically insignificant PCa while not missing clinically significant cancer as it has been associated with characteristics indicative of tumor aggressiveness such as tumor volume&#44; tumor grade&#44; and Gleason score&#46;<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">8&#8211;10</span></a> Used in conjunction with established imaging modalities and serological and clinical data&#44; PCA3 may also be a useful marker to improve the selection of patients suitable for active surveillance or focal therapy&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The purpose of this study was to evaluate the yield of PCA3 as an additional test in the management of patients with suspected PCa and to investigate whether our previously published results&#44; in a prospective study of 598 patients&#44; would be confirmed&#46;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">11</span></a> Moreover&#44; the association of PCA3 with the new Grade Groups proposed by the International Society of Urological Pathology &#40;ISUP&#41; in 2014 was evaluated&#46;<a class="elsevierStyleCrossRefs" href="#bib0210"><span class="elsevierStyleSup">12&#8211;14</span></a></p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Patients and methods</span><p id="par0020" class="elsevierStylePara elsevierViewall">This retrospective study included data from consecutive patients with suspected PCa and candidates for prostate biopsy who attended the urology department between November 2009 and April 2016&#46; A protocol for the study&#44; including inclusion and exclusion criteria&#44; and a copy of the informed consent form to be signed by patients were approved by the Ethics Committee of our institution&#46;</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Samples and patients</span><p id="par0025" class="elsevierStylePara elsevierViewall">A total of 1038 urine samples collected after prostate massage were studied in our laboratory within the period stated above&#46; For inclusion in this study&#44; sample collection had to be indicated by one of the following&#58; elevated PSA and prior negative biopsy&#44; altered PSA but lower than 10<span class="elsevierStyleHsp" style=""></span>ng&#47;ml without prior biopsy&#44; altered PSA and presence of a well-known prostatic inflammatory disease &#40;prostatitis or BPH&#41;&#44; or high PSA level in the presence of a comorbidity giving rise to an increased biopsy-associated risk&#46; Samples corresponding to patients with previous PCa diagnoses &#40;71&#41; were excluded&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">A total of 967 urine samples corresponding to 814 patients were included&#59; 132 patients had more than one sample studied during their clinical follow-up&#46; When comparative statistical analysis with other clinical variables &#40;age&#44; serum PSA&#44; presence of prostatitis&#44; and prostate volume&#41; was performed&#44; only the latest study data were used&#44; resulting in the exclusion of 153 urine samples&#46; Data recorded included&#58; age&#44; total PSA &#40;ng&#47;ml&#41; and prostate volume &#40;cc&#41; of all patients&#46; When a biopsy was performed&#44; the number of cylinders obtained was recorded and when a PCa was diagnosed&#44; the number of affected cylinders&#44; the percentage of tumor&#44; the Gleason score&#44; and the Grade Group were also recorded&#46; In cases diagnosed as PCa before publication of the Gleason Grade Group guidelines&#44; the Gleason score was converted to its corresponding Grade Group according to published instructions&#46;<a class="elsevierStyleCrossRefs" href="#bib0210"><span class="elsevierStyleSup">12&#8211;14</span></a></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">PCA3 determination</span><p id="par0035" class="elsevierStylePara elsevierViewall">The first voided urine after DRE with prostatic massage consisting in three palpations per lobe was collected and tested with the Progensa&#8482; PCA3 Assay kit &#40;GenProbe&#41; following the manufacturer&#39;s instructions&#46; The kit quantifies PCA3 and PSA mRNA molecules and generates a PCA3 score &#40;s-PCA3&#41; according to the formula&#58; &#40;PCA3 mRNA&#47;PSA mRNA&#41;<span class="elsevierStyleHsp" style=""></span>&#215;<span class="elsevierStyleHsp" style=""></span>1000&#46; The s-PCA3 was considered positive when it was 35 or higher&#44; and only in these cases was a prostate biopsy recommended owing to the high probability of detecting PCa&#46;<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">15</span></a> However&#44; the final decision whether or not to perform a biopsy was the responsibility of the patient&#39;s physician&#46; When the association between PCA3 and the parameters of tumor aggressiveness was analyzed&#44; the s-PCA3 cut-off was established at 50&#44; in accordance with previous studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0205"><span class="elsevierStyleSup">11&#44;16&#44;17</span></a></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Prostate biopsy protocol</span><p id="par0040" class="elsevierStylePara elsevierViewall">Transrectal ultrasound-guided prostate biopsies were performed in an operating room with patients under anesthesia with sedation&#46; A minimum of five cylinders per lobe were obtained&#44; with additional cores when suspicious nodules were detected by DRE or ultrasound&#46; In those patients who had a previous negative biopsy&#44; a minimum of ten cylinders per lobe were obtained&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Histopathological study</span><p id="par0045" class="elsevierStylePara elsevierViewall">Two pathologists performed the histopathological study on serial sections of formalin-fixed paraffin-embedded tissue stained with hematoxylin&#8211;eosin&#46; Immunohistochemical study with Alpha Ethylacyl-CoA-Racemase &#40;AMACR&#41; and basal cell markers &#40;p63 and 34&#946;E12 cytokeratins&#41; was performed when requested by the pathologist&#46; The diagnostic entities covered were&#58; prostate adenocarcinoma &#40;PCa&#41;&#44; atypical small acinar proliferation &#40;ASAP&#41;&#44; high-grade prostatic intraepithelial neoplasia &#40;HGPIN&#41;&#44; chronic prostatitis&#44; other non-neoplastic processes&#44; and normality&#46; In PCa cases the grade was determined based on the Gleason patterns <a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">18</span></a>and the Grade Group&#46;<a class="elsevierStyleCrossRefs" href="#bib0210"><span class="elsevierStyleSup">12&#8211;14</span></a> The new ISUP grading system for prostatic adenocarcinoma classifies PCa into five prognostically distinct Grade Groups &#40;1&#8211;5&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">12</span></a> This classification reflects prostate cancer biology more accurately than the Gleason score&#46; The Grade Group 1 comprises patients with Gleason &#40;3<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>3&#41; PCa&#44; mostly with an excellent prognosis and no potential lymph node involvement&#59; such patients are suitable for active surveillance although other clinical information must be considered for optimum treatment&#46;<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">19</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">The ASAP category was reserved for microglandular proliferations that displayed morphological and immunohistochemical characteristics suspicious for PCa &#40;loss of basal layer and&#47;or expression of AMACR&#41; but were insufficiently represented in biopsies to support a definitive diagnosis of PCa&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">In cases diagnosed as PCa&#44; the presence of tumor in more than 33&#37; of the cylinders was considered an indicator of tumor stage&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Statistical analysis</span><p id="par0060" class="elsevierStylePara elsevierViewall">Hypothetical associations between pairs of variables were analyzed using Fisher&#39;s exact test for the categorical variables and linear regression analysis for the continuous variables&#46; To determine the association between a shortlist of three categorical variables&#44; the best log-linear model was established using the stepwise algorithm and the Akaike information criterion starting from the full model&#44; i&#46;e&#46; with all possible interactions among the three variables&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">20</span></a> In order to investigate whether s-PCA3 could predict the Grade Group&#44; a logistic model was applied&#46;<a class="elsevierStyleCrossRef" href="#bib0255"><span class="elsevierStyleSup">21</span></a> All statistical analyses were performed with the R software&#46;<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">22</span></a></p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Results</span><p id="par0065" class="elsevierStylePara elsevierViewall">A total of 967 urine samples corresponding to 814 patients with a mean age of 65&#46;8 years &#40;SD 8&#46;1 years&#41; were included&#46; Most of the s-PCA3 tests &#40;91&#46;7&#37;&#41; were performed in patients with elevated PSA and a negative previous biopsy or alterations in PSA levels not exceeding 10<span class="elsevierStyleHsp" style=""></span>ng&#47;ml &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; A valid result was obtained in 98&#46;5&#37; of samples&#46; The mean s-PCA3 value was 48&#46;7&#46; Details of the numeric variables analyzed are reported in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#46; The s-PCA3 showed a very weak significant relationship with age &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#44; with 5&#46;4&#37; of the variability explained by the s-PCA3&#41; and no significant relation with serum PSA level &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;798&#41;&#44; presence of prostatitis &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;826&#41;&#44; or prostate volume &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;130&#41;&#46; 522 samples corresponding to 431 patients had a negative s-PCA3&#46; In these cases&#44; accounting for 54&#37; of the samples and 52&#46;9&#37; of patients&#44; no biopsy was recommended&#59; however&#44; 37 of these patients did undergo a biopsy following their urologists&#8217; criteria&#46; 24 &#40;5&#46;6&#37;&#41; patients had a negative biopsy&#44; of whom two &#40;0&#46;5&#37;&#41; were diagnosed with HGPIN&#44; one &#40;0&#46;2&#37;&#41; with ASAP&#44; and 10 &#40;2&#46;3&#37;&#41; with PCa &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46; The rest of the patients with a negative s-PCA3 were managed by their urologists&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0070" class="elsevierStylePara elsevierViewall">In patients with samples that had a positive s-PCA3 &#40;44&#46;5&#37;&#41;&#44; a subsequent biopsy was recommended&#46; Of the 151 biopsies studied&#44; 56&#46;3&#37; yielded a diagnosis of PCa&#44; 4&#46;6&#37; ASAP&#44; and 6&#37; HGPIN&#44; while 33&#46;1&#37; showed no evidence of malignancy &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46; When the s-PCA3 cut-off was set to 50 instead of 35&#44; the percentage of PCa increased to 59&#46;5&#37; and the percentage of biopsies with no evidence of malignancy decreased to 30&#46;2&#37;&#44; while the percentages of ASAP and HGPIN did not change significantly&#46; The probability of a positive biopsy increased as the s-PCA3 increased &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;041&#41;&#46; The percentage of cylinders with carcinoma detected in the biopsy was assessed in 75 of the 85 cases with a diagnosis of PCa&#59; the 10 remaining cases were surgical resection specimens&#46; The percentage of affected cylinders increased as the s-PCA3 increased&#44; the relationship being statistically significant &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;015&#41;&#46; In no patient with a diagnosis of PCa and an s-PCA3 between 35 and 50 no more than 33&#37; of cylinders were affected &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46; The s-PCA3 and the Gleason score showed a statistically significant relationship &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; Of those cases with an s-PCA3 greater than 50&#44; 76&#46;8&#37; had a Gleason score<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>7 &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; The best log-linear model&#44; including s-PCA3&#44; the Gleason score&#44; and the percentage of affected cylinders&#44; retained in the final equation the interactions between s-PCA3 and percentage of affected cylinders &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;002&#41; and between s-PCA3 and the Gleason score &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;000&#41;&#44; confirming the relationship shown previously with Fisher&#39;s exact test&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0075" class="elsevierStylePara elsevierViewall">Only one patient in this series was in Grade Group 5&#46; For the purpose of all statistical analyses&#44; this patient was grouped with those in Grade Group 4&#46; A statistically significant relationship was observed between s-PCA3 and the Grade Group &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;008&#41;&#46; Of PCa patients with a positive s-PCA3 lower than 50&#44; 68&#46;8&#37; were in Grade Group 1 &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46; The best log-linear model&#44; including s-PCA3&#44; the Grade Group&#44; and the percentage of affected cylinders&#44; retained in the final equation the interactions between s-PCA3 and percentage of affected cylinders &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;002&#41; and between s-PCA3 and the Grade Group &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;003&#41;&#44; confirming the relationship shown previously with Fisher&#39;s exact test &#40;<a class="elsevierStyleCrossRef" href="#fig0020">Fig&#46; 4</a>&#41;&#46; A logistic model was employed to test whether s-PCA3 and the percentage of affected cylinders could predict the Grade Group&#46; A statistically significant relationship between the three variables was confirmed&#44; as was shown previously by Fisher&#39;s exact test and the log-linear model&#46; At a cut-off point of 0&#46;625&#44; the sensitivity and specificity of the model were 79&#37; and 64&#37; respectively&#59; the positive predictive value was 84&#37; and the negative predictive value was 56&#37;&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><elsevierMultimedia ident="fig0020"></elsevierMultimedia></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Discussion</span><p id="par0080" class="elsevierStylePara elsevierViewall">In this series the s-PCA3 was not related to PSA level&#44; prostate volume&#44; or presence of prostatitis&#44; in agreement with data published in previous studies<a class="elsevierStyleCrossRefs" href="#bib0265"><span class="elsevierStyleSup">23&#8211;25</span></a>&#59; moreover&#44; only a very weak significant relationship was found with patient age&#46; Incorporation of the PCA3 study into PCa screening significantly reduced &#40;by 54&#37;&#41; the indication for biopsy&#44; in accordance with previously published data&#46;<a class="elsevierStyleCrossRefs" href="#bib0205"><span class="elsevierStyleSup">11&#44;17&#44;28&#44;29</span></a> In patients with a positive s-PCA3&#44; the percentage of positive biopsies was markedly increased &#40;to 60&#46;9&#37;&#44; including ASAP&#41; compared with the percentage in biopsies indicated by PSA and DRE alone&#46; There was a statistically significant relationship between s-PCA3 and the presence of PCa in the subsequent biopsy&#44; as has been reported previously&#46;<a class="elsevierStyleCrossRefs" href="#bib0230"><span class="elsevierStyleSup">16&#44;25&#44;26</span></a> The s-PCA3 was not able to predict the presence of PCa in ten patients in the series&#46; This percentage of false negative results is in accordance with that reported by the PCA3 kit manufacturer&#46; The relation between s-PCA3 and different parameters associated with tumor aggressiveness&#44; such as Gleason score and the percentage of cylinders in which PCa was detected&#44; was also analyzed&#46; All of the latter parameters showed a statistically significant relationship with s-PCA3&#46; None of the patients with a positive s-PCA3 below 50 showed more than 33&#37; of cylinders affected by PCa and 68&#46;8&#37; of them had a Gleason score below 7&#46; In contrast&#44; 76&#46;8&#37; of patients with an s-PCA3 over 50 had a Gleason score higher than or equal to 7&#46; These results are in agreement with previously published data from reviews and meta-analyses and also confirm our previous results&#46;<a class="elsevierStyleCrossRefs" href="#bib0205"><span class="elsevierStyleSup">11&#44;16&#44;26&#44;27</span></a> To our knowledge this is the first time that the relation between s-PCA3 and the new Grade Group has been explored&#46; In this series there was a statistically significant relationship between s-PCA3 and the Grade Group&#46; These results were confirmed in two log-linear models&#46; The high prevalence of low Grade Group tumors in patients with PCa and a positive PCA3 lower than 50 may warrant recommendation of a conservative clinical attitude in this subgroup&#46; A logistic model was designed in order to analyze whether s-PCA3 could predict the Grade Group in patients with PCa&#46; This model once more confirmed a strong relationship between s-PCA3 and the Grade Group&#46; However&#44; its predictive capacity was weak&#44; probably owing to the small size of the series&#44; and more data are needed in order to confirm these preliminary results&#46; In our series&#44; 68&#46;6&#37; of PCa with a positive s-PCA3 below 50 were in Grade Group 1&#44; indicating that subsequent biopsy could be avoided or delayed in this patient subgroup&#44; with a watchful waiting strategy instead being adopted unless contraindicated by other clinical information&#46; In contrast&#44; the 76&#46;8&#37; of patients in our series with an s-PCA3 higher than 50 were assigned to Grade Groups 2&#8211;5&#44; suggesting that a more aggressive therapeutic approach may be adequate&#46; Although some series<a class="elsevierStyleCrossRef" href="#bib0300"><span class="elsevierStyleSup">30</span></a> do not reach the same conclusion&#44; when all the results are considered&#44; in addition to the new evidence showing a significant relationship between s-PCA3 and the Grade Group&#44; they confirm that s-PCA3 has prognostic significance in prediction of the aggressiveness of PCa&#44; as suggested by previous studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0205"><span class="elsevierStyleSup">11&#44;17&#44;26&#44;27</span></a></p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Conclusions</span><p id="par0085" class="elsevierStylePara elsevierViewall">In this retrospective study we reaffirmed our previously published results showing that s-PCA3 outperforms PSA in predicting biopsy diagnosis of PCa&#46; Moreover&#44; the prognostic significance of s-PCA3 was confirmed&#44; as it was associated with parameters of tumor aggressiveness such as tumor volume and Gleason score&#46; Importantly&#44; to our knowledge this is the first time that an association has been demonstrated between s-PCA3 and the new Grade Group&#46; In conclusion&#44; s-PCA3 may serve as an additional marker to reduce the indication for biopsies and to avoid overdiagnosis and overtreatment of patients with suspected PCa&#46; Moreover&#44; insofar as it is predictive of the Grade Group and tumor extension&#44; s-PCA3 can provide information of prognostic significance&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Conflict of interests</span><p id="par0090" class="elsevierStylePara elsevierViewall">The authors declare no conflict of interest&#46;</p></span></span>"
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            0 => "<span class="elsevierStyleItalic">Gleason</span> grade"
            1 => "Prostate Grade Group"
            2 => "PCA3"
            3 => "PSA"
            4 => "Screening"
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          "palabras" => array:5 [
            0 => "Grado de Gleason"
            1 => "Grado grupo pr&#243;stata"
            2 => "PCA3"
            3 => "PSA"
            4 => "<span class="elsevierStyleItalic">Screening</span>"
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      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Purpose</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To evaluate the PCA3 &#40;Prostate Cancer 3 gene&#41; as a tool to improve prostate cancer &#40;PCa&#41; screening and its capability to predict PCa aggressiveness&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Patients and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A retrospective study with data from consecutive patients with suspected PCa seen in the urology department between November 2009 and April 2016 and who were candidates for prostate biopsy&#46; A total of 1038 urine samples were tested in our laboratory with a kit that generated a PCA3 score &#40;s-PCA3&#41;&#46; A prostate biopsy was recommended only in those patients with s-PCA3<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>35&#46; Associations between variables were analyzed using the R software&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">In patients with a positive s-PCA3 &#40;44&#46;5&#37;&#41;&#44; a subsequent biopsy was recommended&#46; Of a total of 151 biopsies studied&#44; 56&#46;3&#37; yielded a diagnosis of PCa&#46; The probability of a positive biopsy increased as the s-PCA3 increased &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;041&#41;&#46; The percentage of affected cylinders increased as the s-PCA3 increased &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;015&#41;&#46; A statistically significant relationship was observed between s-PCA3 and both the Gleason score and the Grade Group &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;001 and 0&#46;008&#44; respectively&#41;&#46; The best log-linear models and a logistic model confirmed the relationships shown previously with Fisher&#39;s exact tests&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">S-PCA3 may serve as an additional marker to reduce the indication for biopsies and avoid overdiagnosis and overtreatment of patients with suspected PCa&#46; The prognostic significance of s-PCA3 was confirmed&#44; as it was associated with tumor volume and Gleason score&#46; Importantly&#44; to our knowledge this is the first time that an association has been demonstrated between s-PCA3 and the new Grade Group&#46;</p></span>"
        "secciones" => array:4 [
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            "identificador" => "abst0005"
            "titulo" => "Purpose"
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            "identificador" => "abst0010"
            "titulo" => "Patients and methods"
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            "titulo" => "Results"
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            "titulo" => "Conclusions"
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      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Evaluar el estudio de PCA3 &#40;gen Prostate Cancer 3&#41; en orina como test complementario para mejorar el cribado de c&#225;ncer de pr&#243;stata &#40;CaP&#41;&#44; as&#237; como su capacidad de predecir la agresividad tumoral antes de la biopsia&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Pacientes y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">En este estudio retrospectivo se incluyeron pacientes consecutivos con sospecha de CaP y candidatos a biopsia&#44; que se presentaron en la consulta del ur&#243;logo entre noviembre de 2009 y abril de 2016&#46; Se testaron en nuestro laboratorio un total de 1&#46;038 muestras de orina con un <span class="elsevierStyleItalic">kit</span> que gener&#243; un PCA3 <span class="elsevierStyleItalic">score</span> &#40;s-PCA3&#41;&#46; Se recomend&#243; la biopsia en aquellos pacientes con s-PCA3<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>35&#46; Las asociaciones entre variables se analizaron con el <span class="elsevierStyleItalic">software</span> R&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">En los pacientes con s-PCA3 positivo &#40;44&#44;5&#37;&#41; se recomend&#243; la realizaci&#243;n de una biopsia&#46; Se estudiaron un total de 151 biopsias de las que un 56&#44;3&#37; fueron diagnosticadas de CaP&#46; La probabilidad de obtener una biopsia positiva aument&#243; a medida que lo hacia el s-PCA3 &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;041&#41;&#46; El porcentaje de cilindros afectados aument&#243; a medida que lo hac&#237;a el s-PCA3 &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;015&#41;&#46; El s-PCA3 present&#243; una relaci&#243;n estad&#237;sticamente significativa con el grado de Gleason &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41; y el grado grupo &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;008&#41;&#46; El mejor modelo Log-lineal&#44; as&#237; como el modelo log&#237;stico confirmaron las relaciones observadas previamente con las pruebas exactas de Fisher&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">El s-PCA3 es una herramienta complementaria que permite reducir la indicaci&#243;n de biopsias y evitar el sobrediagn&#243;stico y sobretratamiento de pacientes con sospecha de CaP&#46; La significaci&#243;n pron&#243;stica del s-PCA3 fue confirmada al demostrarse su asociaci&#243;n con el volumen tumoral y el grado de Gleason&#46; Seg&#250;n la informaci&#243;n de la que disponemos&#44; este es el primer estudio en el que se demuestra la asociaci&#243;n entre el s-PCA3 y el nuevo sistema de gradaci&#243;n del CaP&#46;</p></span>"
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            "titulo" => "Resultados"
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                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Indication for the s-PCA3 study&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">No&#46; of samples &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Negative prior biopsy&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">420 &#40;43&#46;4&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">Risk factors for biopsy&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Known benign prostate pathology&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">27 &#40;2&#46;8&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">No specified indication&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">23 &#40;2&#46;4&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Total&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Total PSA &#40;ng&#47;ml&#41;&nbsp;\t\t\t\t\t\t\n
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                  <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="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">s-PCA3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Samples &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Patients &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " rowspan="4" align="left" valign="top">&#60;35</td><td class="td" title="table-entry  " rowspan="4" align="char" valign="top">522 &#40;54&#41;</td><td class="td" title="table-entry  " rowspan="4" align="char" valign="top">431 &#40;52&#46;9&#41;</td><td class="td" title="table-entry  " rowspan="4" align="char" valign="top">37</td><td class="td" title="table-entry  " align="left" valign="top">Non pathologic&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">24&#47;37 &#40;64&#46;9&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">24&#47;431 &#40;5&#46;6&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">ASAP&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">1&#47;37 &#40;2&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">1&#47;431 &#40;0&#46;2&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">HGPIN&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2&#47;37 &#40;5&#46;4&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2&#47;431 &#40;0&#46;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="table-entry ; entry_with_role_rowhead " align="left" valign="top">PCa&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">10&#47;37 &#40;27&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">10&#47;431 &#40;2&#46;3&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="7" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry  " rowspan="4" align="left" valign="top">&#8805;35</td><td class="td" title="table-entry  " rowspan="4" align="char" valign="top">430 &#40;44&#46;5&#41;</td><td class="td" title="table-entry  " rowspan="4" align="char" valign="top">379 &#40;46&#46;6&#41;</td><td class="td" title="table-entry  " rowspan="4" align="char" valign="top">151</td><td class="td" title="table-entry  " align="left" valign="top">Non pathologic&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">50&#47;151 &#40;33&#46;1&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">50&#47;379 &#40;13&#46;2&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">ASAP&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">7&#47;151 &#40;4&#46;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">7&#47;379 &#40;1&#46;8&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">HGPIN&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">9&#47;151 &#40;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">9&#47;379 &#40;2&#46;4&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">PCa&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">85&#47;151 &#40;56&#46;3&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">85&#47;379 &#40;22&#46;4&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="7" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">N&#46;V&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">15 &#40;1&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">4 &#40;0&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="7" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Total&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">967 &#40;100&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">814 &#40;100&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">188&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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Información del artículo

ISSN: 16998855
Idioma original: Inglés

DOI:10.1016/j.patol.2018.04.003

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