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Original article
High intensity focused ultrasound with Focal-One® device: Prostate-specific antigen impact and morbidity evaluation during the initial experience
Ultrasonido focalizado de alta intensidad con el dispositivo Focal-One®: impacto sobre el antígeno prostático específico y evaluación de la morbilidad durante la experiencia inicial
J.I. Perez-Reggetia, R. Sanchez-Salasa,
Corresponding author
rafael.sanchez-salas@imm.fr

Corresponding author.
, A. Sivaramana, E. Linares Espinosa, A.E. de Gracia-Nietoa, E. Barreta, M. Galianoa, F. Rozeta, A. Fregevilleb, R. Renard-Pennac, N. Cathalaa, A. Mombeta, D. Prapotnicha, X. Cathelineaua
a Departamento de Urología, Institut Mutualiste Montsouris, París, France
b Departamento de Radiología, Institut Mutualiste Montsouris, París, France
c Departamento de Radiología, Pitié-Salpêtrière Hospital, París, France
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        "titulo" => "Ultrasonido focalizado de alta intensidad con el dispositivo Focal-One<span class="elsevierStyleSup">&#174;</span>&#58; impacto sobre el ant&#237;geno prost&#225;tico espec&#237;fico y evaluaci&#243;n de la morbilidad durante la experiencia inicial"
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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; treatment with high-intensity focused ultrasound &#40;HIFU&#41; began in the early 1990s by Dr&#46; Albert Gelet et al&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">1</span></a> This therapy is hyperthermia based and induces a coagulative necrosis of the prostate tissue by thermal and mechanical effect and the ablative zone is demonstrable as early as 2<span class="elsevierStyleHsp" style=""></span>h after the procedure&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">2</span></a> Originally&#44; HIFU was employed for patients with low or intermediate-risk localized PCa&#44; who were not candidates for surgery&#44; or as a salvage treatment for patients who were previously treated with external radiotherapy &#40;EBRT&#41;&#44; for whom a whole gland ablation was performed&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Today&#44; European Urology Association guidelines recommend active surveillance&#44; radical prostatectomy&#44; or EBRT as the standard treatment for localized PCa&#44; depending on the tumor stage and the patient&#39;s life expectancy&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">4</span></a> HIFU technology has evolved over the past decade and can be a viable treatment alternative in selected patients with low&#47;intermediate-risk PCa as a focal treatment with promising oncological and functional results&#44; in addition to low perioperative complication rates&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">5&#44;6</span></a> Currently&#44; there are three devices available&#58; Ablatherm<span class="elsevierStyleSup">&#174;</span> and Focal-One<span class="elsevierStyleSup">&#174;</span> from EDAP-TMS &#40;France&#41;&#44; and Sonablate<span class="elsevierStyleSup">&#174;</span> from SonaCare Medical &#40;USA&#41;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">7</span></a> and Focal-One<span class="elsevierStyleSup">&#174;</span> represent the newer generation of HIFU devices with significant technical upgrade&#46; In this paper&#44; we report the initial clinical experience of Focal-One<span class="elsevierStyleSup">&#174;</span> device in the PCa treatment&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Methods and materials</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Patients</span><p id="par0015" class="elsevierStylePara elsevierViewall">We performed a retrospective analysis of our prospectively collected database of patients with localized PCa&#44; treated with Focal-One<span class="elsevierStyleSup">&#174;</span> HIFU device between June 2014 and October 2015&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">With Focal-One<span class="elsevierStyleSup">&#174;</span> we performed focal &#40;hemiablation&#47;sub-total&#41; and whole-gland treatment&#46; The clinical criteria for inclusion to perform focal treatment were&#58; Clinical stage T1c-T2a&#44; maximum positive biopsy&#58; 33&#37;&#44; Gleason &#8804;7 &#40;3<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>4&#41;&#44; prostate-specific antigen &#40;PSA&#41; &#60;15<span class="elsevierStyleHsp" style=""></span>ng&#47;ml&#44; absence of extraprostatic disease at the multiparametric magnetic resonance imaging &#40;mpMRI&#41;&#44; and life expectancy &#62;10<span class="elsevierStyleHsp" style=""></span>y&#46; Total treatment was performed for patients with a bilateral disease&#44; or for those not candidates for surgery&#46; Those in salvage treatment received focal or total treatment&#44; according to an individual analysis for each case&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Cancer localization</span><p id="par0025" class="elsevierStylePara elsevierViewall">For PCa diagnosis and localization&#44; we performed to all patients&#58; histological diagnosis with prostate biopsy using 5<span class="elsevierStyleHsp" style=""></span>mm intervals transperineal mapping &#40;TPMB&#41;&#44; and image diagnosis with mpMRI&#46; On those patients with visible lesion on&#44; an expert radiologist performed the contouring of the prostate and the regions of interest &#40;ROI&#41; using a computer program&#44; in order to be used for guidance during the procedure&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Treatment</span><p id="par0030" class="elsevierStylePara elsevierViewall">The treatment was performed under general anesthesia using the Focal-One<span class="elsevierStyleSup">&#174;</span> device &#40;EDAP TMS&#44; Vaulx-en-Velin&#44; France&#41;&#46; Focal-One<span class="elsevierStyleSup">&#174;</span> uses a 3<span class="elsevierStyleHsp" style=""></span>MHz transducer for the treatment combined with a 7&#46;5<span class="elsevierStyleHsp" style=""></span>MHz image transducer&#46; During the shooting phase&#44; the software automatically controls the rectal position&#44; and the cooling system maintains the rectal mucosa temperature at 14<span class="elsevierStyleHsp" style=""></span>&#176;C&#46; The focal point position inside the prostate was controlled in real time by the surgeon&#46; For this procedure&#44; the transducer was inserted into the rectum with the patient in right lateral position &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">Treatment planning was guided by ultrasound with elastic fusion of mpMRI images&#44; localizing the ROI when it was radiologically visible&#46; The urologist performed the prostate contour on the ultrasound image during the procedure&#46; A safety margin was established at 4&#8211;6<span class="elsevierStyleHsp" style=""></span>mm from the sphincter to prevent damage&#46; At the end of the HIFU&#44; a contrast-enhanced ultrasound &#40;CEUS&#41; was performed with Sonovue<span class="elsevierStyleSup">&#174;</span> to check the treated area&#46; After treatment&#44; a bladder catheter was placed&#46; Patients with prostate volumes &#62;40<span class="elsevierStyleHsp" style=""></span>cc or with symptoms of lower urinary tract &#40;IPSS<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>8&#41;&#44; underwent a transurethral resection of the prostate &#40;TURP&#41;&#44; a month before or during the same treatment&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Outcome measurement</span><p id="par0040" class="elsevierStylePara elsevierViewall">Before the treatment&#44; patients completed these questionnaires&#58; International Prostate Symptom Score &#40;IPSS&#41;&#44; International Continence Society &#40;ICS&#41;&#44; and International Index of Erectile Function &#40;IIEF-5&#41; for assessment of the baseline functional status&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Follow-up visits were conducted at 1&#44; 3&#44; 6&#44; and 12 months and during each visit a physical examination&#44; and completion of the IPSS&#44; ICS and IIFE-5 questionnaires&#46; Patients having no involuntary urine leak and being completely pad free&#44; were defined as continent&#46; The oncological follow-up included PSA measurement on each visit&#44; and the transrectal protocol biopsy &#40;12 core&#44; bisextant&#41; with a mpMRI at 1 year after treatment&#46; Treatment failure was defined as a positive biopsy in the treated area&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The Martin&#8211;Donat criteria were followed to report the surgical complications&#44; and severity of complications was recorded according to the Clavien classification&#46;</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Results</span><p id="par0055" class="elsevierStylePara elsevierViewall">During the described period&#44; 85 patients were treated with HIFU&#44; using Focal-One<span class="elsevierStyleSup">&#174;</span>&#46; Median age was 70 years &#40;IQR&#58; 66&#8211;77&#41;&#44; with a median PSA of 7&#46;79<span class="elsevierStyleHsp" style=""></span>ng&#47;ml &#40;IQR&#58; 6&#46;32&#8211;9&#46;16&#41;&#46; The baseline and the treatment characteristics are summarized in <a class="elsevierStyleCrossRefs" href="#tbl0005">Tables 1 and 2</a>&#44; respectively&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">The mean hospital stay was 1&#46;8 days &#40;range 0&#8211;7&#41; and the mean catheterization time was 2 days &#40;range 1&#8211;6&#41;&#46; Perioperative complications were observed in 13 patients &#40;15&#37;&#41;&#44; all Clavien 2&#44; during the first 30 days post-treatment&#46; At the analysis by type of treatment&#44; the complication rate was 11&#37; for focal treatment and 29&#37; for whole-gland treatment&#46; One patient had a postoperative stroke and the remaining 12 had an acute urinary retention &#40;AUR&#41; subsequent to the removal of the bladder catheter&#44; requiring temporary re-insertion of catheter&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">The median follow-up was 3 months &#40;IQR&#58; 2&#8211;8&#41; and the average PSA decrease 54&#37; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; Nine patients had rising PSA after treatment&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0070" class="elsevierStylePara elsevierViewall">Functional results&#58; At 3 months post treatment&#44; all patients were continent&#46; The median pre-treatment IIEF5-5 dropped from 24 &#40;IQR&#58; 20&#8211;24&#41; to 16 &#40;IQR&#58; 4&#8211;23&#41; post-treatment&#44; while the median IPSS varied from 3 &#40;IQR&#58; 1&#8211;5&#41; to 4&#46;5 &#40;IQR&#58; 0&#8211;8&#41; pre- and post-treatment respectively&#46; Sexual potency was maintained in 83&#37; of the sexually active patients before treatment&#59; while in the type of treatment analysis&#44; 87&#37; of focal treated patients&#44; and 67&#37; of the total treated patients maintained this function&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Discussion</span><p id="par0075" class="elsevierStylePara elsevierViewall">We report our initial experience in the treatment of PCa with HIFU using the Focal-One<span class="elsevierStyleSup">&#174;</span> device&#46; This series shows an average decline in postoperative PSA values of 54&#37; and a suitable percentage of complications&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">In order to guarantee the success of this therapy&#44; the right selection of patients to be treated with HIFU is fundamental&#59; therefore&#44; different factors should be considered prior to treatment&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">8</span></a> In our series&#44; prostate biopsies were performed using TPMB for the identification and histological localization of the tumor&#46; This type of approach allows for a more rigorous diagnosis&#44; making it possible to identify more aggressive diseases with a better accuracy of the tumor size and its Gleason classification&#44; as well as the localization of anterior lesions&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">9</span></a> On the other hand&#44; the biopsy guided by image fusion is recommended by different experts<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">10</span></a> and it will possibly be the tool used for histological diagnosis&#44; in the near future&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">It is important to consider that the maximum postero-anterior treatable distance by Focal-One<span class="elsevierStyleSup">&#174;</span> is 40<span class="elsevierStyleHsp" style=""></span>mm&#59; therefore&#44; anterior lesions in prostates &#62;40<span class="elsevierStyleHsp" style=""></span>cc could be treated improperly&#46; Patients with obstructive lower urinary tract symptoms have an increased risk of an AUR after treatment with HIFU&#46;<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">8&#44;11</span></a> Consequently&#44; it is necessary to perform a TURP for both cases&#46; For the first case&#44; a TURP must be performed 4&#8211;6 weeks before HIFU&#44; to reduce prostate volume&#59; and for the second case&#44; it must be done during the same HIFU treatment&#44; in order to avoid AUR&#46; Different series have reported better functional and quality of life results when HIFU is associated with a TURP&#46;<a class="elsevierStyleCrossRefs" href="#bib0180"><span class="elsevierStyleSup">11&#8211;13</span></a> In our population&#44; prostates &#62;40<span class="elsevierStyleHsp" style=""></span>g&#44; or patients with obstructive symptoms &#40;22 patients&#41; underwent TURP prior to treatment with HIFU&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">Currently&#44; mpMRI is essential for imaging diagnosis of PCa&#46;<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">14</span></a> New technologies allow for image fusion between mpMRI and HIFU treatment in real time&#44; admitting a live comparison of the area that is being treated and the location of the lesion&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">5&#44;7</span></a> We consider a close relationship between urologist and specialized radiologist fundamental&#44; in order to define correctly the ROI to be treated&#46; In our series&#44; 50 treatments were performed using image fusion of intraoperative ultrasound and mpMRI with the previously defined ROI&#46; It is noteworthy that the image fusion as a guide&#44; in biopsies for diagnosis of PCa&#44; is currently employed<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">15</span></a>&#59; however&#44; its use for real-time treatment is still in a developing phase&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">7</span></a> The result of the fusion depends on a prostatic contour made on different time frames by the radiologist &#40;preoperative mpMRI&#41; and by the urologist &#40;preoperative ultrasound&#41;&#44; which may cause differences in the correlation that should be improved in the future&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">CEUS with sulfur hexafluoride &#40;Sonovue<span class="elsevierStyleSup">&#174;</span>&#41; is used for the characterization of abdominal tumors &#40;hepatocellular carcinoma&#44; renal cell carcinoma&#44; etc&#46;&#41;&#44; assessment of perfusion of different organs&#44; and for the control after ablative therapies of different malignancies&#46;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">16</span></a> The use of this promising tool is to distinguish between avascularized tissue and viable tissue post-HIFU<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">17</span></a> &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46; In our study&#44; this radiological study was performed in 28 cases and was very useful for verification of the treated area&#59; however&#44; the correlation between these avascularized areas and the treatment effectiveness is yet to be proven&#46; The objective of this procedure is to verify areas with no vascular changes that could correspond to not adequately treated areas&#44; being possible to be re-treated in the same treatment&#46; In the same way&#44; CEUS can be correlated with a postoperative mpMRI&#44; which could guide the oncological follow-up&#46;<a class="elsevierStyleCrossRef" href="#bib0215"><span class="elsevierStyleSup">18</span></a> The Sonovue<span class="elsevierStyleSup">&#174;</span> is contraindicated in the recent acute coronary syndrome&#44; unstable ischemic cardiomyopathy and other cardiovascular diseases&#46;<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">19</span></a></p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0100" class="elsevierStylePara elsevierViewall">We obtained a 15&#37; rate of perioperative complications&#44; most frequently observed in whole-gland treatments as expected&#46; The vast majority were AURs resolved with the placement of a bladder catheter and its subsequent withdrawal&#46; No major complications or recto-urethral fistulas &#40;RUF&#41; were observed to date&#46; These results correspond to those described in various literatures where AURs occur in up to 20&#37; of cases&#44; RUF &#60;2&#37;&#44; and urinary tract infections in 1&#46;8&#8211;47&#46;9&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">20</span></a> It is noteworthy that our institution was based on a wide experience using Ablatherm HIFU device allowing for a transition of technologies with a facilitated learning curve&#46; That said&#44; assimilating the technological paraphernalia is complex in the former cases&#44; and the presence of urological and technological procurators was a great help to advance in our program&#46; At the same time&#44; the radiologist should be familiar with the contour image program&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">One limitation of our study is that our population is composed of different types of treatments &#40;Hemiablation&#47;Total and Primary&#47;Salvage&#41;&#59; however&#44; we objectify a decrease of &#62;50&#37; in PSA values&#46; In our series&#44; 9 patients had rising PSA after treatment&#59; of which 2 are free of disease&#44; in 1 residual disease was observed and 6 are awaiting the control biopsy&#46; Cordero Feijoo et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">5</span></a> report that the ASTRO&#39;s criteria of biochemical recurrence and the Phoenix criteria have questionable value in focal therapy&#44; so new strategies for biochemical follow-up with PSA should be evaluated&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">All our patients undergo mpMRI after a month of treatment and then after a year of treatment before the control biopsy&#44; this test has great accuracy to determine the extent of damage that has occurred with the HIFU treatment&#44; with the drawback that it is unable to predict histological results<a class="elsevierStyleCrossRef" href="#bib0230"><span class="elsevierStyleSup">21</span></a> &#40;<a class="elsevierStyleCrossRef" href="#fig0020">Fig&#46; 4</a>&#41;&#46;</p><elsevierMultimedia ident="fig0020"></elsevierMultimedia><p id="par0115" class="elsevierStylePara elsevierViewall">These factors make it mandatory that patients treated with HIFU should be included in protocols with control prostate biopsy after a year of follow-up&#46; We emphasize that HIFU treatment is non-invasive&#44; non-ionizing&#44; having no long-term cumulative effects&#44; allowing for it to be repeated&#44; considered an advantage over other ablative therapies&#46;<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">20</span></a></p><p id="par0120" class="elsevierStylePara elsevierViewall">Continence was not affected in any patient&#59; however&#44; as described in other series&#44; there was a decline in erectile function at 3 months post-treatment&#46;<a class="elsevierStyleCrossRef" href="#bib0235"><span class="elsevierStyleSup">22</span></a> Despite this&#44; &#62;80&#37; of previously potent patients reported erections sufficient for penetration after treatment&#46; Noting that&#44; in those patients who received total prostate treatment&#44; this function was only maintained in 67&#37; of cases&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">During HIFU treatment&#44; there can be dissipation of ultrasound waves in longer focal points&#46; The resulting prostatic edema can potentially displace the target from the firing zone during treatment&#46; This is particularly true when ablating cancers in anterior zones&#44; the US waves need to travel a longer distance to reach the focal point and after few initial passages&#44; the intervening prostatic tissue undergoes edema resulting in pushing the target area further away&#46; Another critical cancer location is the apex close to the sphincters&#59; most of the focal therapy experience worldwide is based on thermal energies &#40;Cryotherapy and HIFU&#41; and these energies are found to cause some degree of sphincteric dysfunction based on the whole gland experience&#46; HIFU is the least invasive of all the currently employed energies for the focal therapy and hence should be offered whenever feasible&#46; PCa most commonly arises from the peripheral zone and more often below the level of the urethra&#46;<a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">23</span></a> HIFU appears to have more advantages in this cancer location considering the shorter focal point and more precise contouring of the target area&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">We are faithful believers of the three pillars proposed by Linder et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">24</span></a> for the focal treatment of PCa&#59; <span class="elsevierStyleItalic">Planning</span>&#58; mpMRI to identify ROI and prostate biopsies by TPMB &#40;or perhaps fusion in the future&#41; are essential tests to be performed for the identification and location of PCa&#59; <span class="elsevierStyleItalic">Treatment&#58;</span> HIFU induces coagulative necrosis&#44; but this occurs at a focal length of 40<span class="elsevierStyleHsp" style=""></span>mm&#44; so prostates &#62;40<span class="elsevierStyleHsp" style=""></span>cc must be previously treated with TURP&#59; likewise&#44; we restrict the use of HIFU for lesions with clear anterior location&#44; adapting the energy use to the location of the tumor within the prostate<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">25</span></a>&#59; <span class="elsevierStyleItalic">Control&#58;</span> CEUS and post-treatment mpMRI allows for checking the area of cavitation and avascularization produced and planning possible extensions of treatment in the same surgical procedure&#46; That said&#44; we must understand that protocol biopsy a year after treatment is mandatory&#46; Up to this point&#44; the Focal-One<span class="elsevierStyleSup">&#174;</span> is the only technology available with the possibility of applying all the pillars of focal therapy&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Conclusions</span><p id="par0135" class="elsevierStylePara elsevierViewall">HIFU treatment using Focal-One<span class="elsevierStyleSup">&#174;</span> is a feasible and safe procedure with fewer complications&#46; Functional results are encouraging with no reported incontinence and sexual function maintained in 83&#37; of the patients&#46; Further analysis should be performed to assess the oncological results of our series&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Conflict of interest</span><p id="par0140" class="elsevierStylePara elsevierViewall">Dr&#46; R Sanchez-Salas &#8211; EDAP TMS consultant&#46;</p></span></span>"
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          "clase" => "keyword"
          "titulo" => "Palabras clave"
          "identificador" => "xpalclavsec764368"
          "palabras" => array:4 [
            0 => "C&#225;ncer de pr&#243;stata"
            1 => "Terapia focal"
            2 => "Ultrasonido focalizado de alta intensidad"
            3 => "Hemiablaci&#243;n"
          ]
        ]
      ]
    ]
    "tieneResumen" => true
    "resumen" => array:2 [
      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">We report our initial experience in the treatment of prostate cancer &#40;PCa&#41; with high-intensity focused ultrasound &#40;HIFU&#41; using the Focal-One<span class="elsevierStyleSup">&#174;</span> device&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Material and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Retrospective review of the prospectively populated database&#46; Between June 2014 and October 2015&#44; 85 patients underwent HIFU &#40;focal&#47;whole-gland&#41; treatment for localized PCa&#46; Preoperative cancer localization was done with multiparametric magnetic resonance imaging &#40;mpMRI&#41; and transperineal mapping biopsies&#46; Treatment was carried out using the Focal-One<span class="elsevierStyleSup">&#174;</span> device under general anesthesia&#46; Oncological follow-up&#58; PSA measurement and control biopsy with mpMRI according to protocol&#46; Questionnaire-based functional outcome assessment was done&#46; Complications were reported using Clavien classification&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The median PSA was 7&#46;79<span class="elsevierStyleHsp" style=""></span>ng&#47;ml &#40;IQR&#58; 6&#46;32&#8211;9&#46;16&#41;&#44; with a median prostate volume of 38<span class="elsevierStyleHsp" style=""></span>cc &#40;IQR&#58; 33&#8211;49&#46;75&#41;&#46; Focal and whole-gland therapy was performed in 64 and 21 patients respectively&#46; Ten patients received salvage HIFU&#46; Complications were encountered in 15&#37; of cases&#44; all Clavien 2 graded&#46; Mean hospital stay was 1&#46;8 days &#40;0&#8211;7&#41; and bladder catheter was removed on day 2 &#40;1&#8211;6&#41;&#46; Mean percentage reduction of PSA was 54&#37;&#46; Median follow-up was 3 months &#40;IQR&#58; 2&#8211;8&#41;&#46; Functional outcomes&#58; All patients were continents at 3 months and potency was maintained in 83&#37; of the preoperatively potent&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Focal-One<span class="elsevierStyleSup">&#174;</span> HIFU treatment appears to be a safe procedure with few complications&#46; Functional outcomes proved no urinary incontinence and sexual function were maintained in 83&#37;&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Objective"
          ]
          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Material and methods"
          ]
          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
          ]
          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusions"
          ]
        ]
      ]
      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivos</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Reportamos nuestra experiencia inicial en el tratamiento del c&#225;ncer de pr&#243;stata &#40;PCa&#41; con ultrasonido focalizado de alta intensidad &#40;HIFU&#41; utilizando el dispositivo Focal-One<span class="elsevierStyleSup">&#174;</span>&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Material y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Estudio retrospectivo de datos recogidos prospectivamente&#46; Entre junio de 2014 y octubre de 2015&#44; 85 pacientes recibieron tratamiento HIFU &#40;focal&#47;total&#41;&#44; para PCa localizado&#46; La localizaci&#243;n preoperatoria del tumor fue realizada con resonancia magn&#233;tica multiparam&#233;trica &#40;mpMRI&#41; y biopsias prost&#225;ticas mediante mapeo transperineal&#46; El tratamiento fue realizado utilizando el dispositivo Focal-One<span class="elsevierStyleSup">&#174;</span> bajo anestesia general&#46; Seguimiento oncol&#243;gico&#58; medici&#243;n del PSA y biopsia control con mpMRI seg&#250;n protocolo&#46; Los resultados funcionales fueron evaluados mediante cuestionarios validados y las complicaciones reportadas utilizando la clasificaci&#243;n Clavien&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">La mediana de PSA fue 7&#44;79<span class="elsevierStyleHsp" style=""></span>ng&#47;ml &#40;6&#44;32-9&#44;16&#41; con una mediana de volumen prost&#225;tico de 38<span class="elsevierStyleHsp" style=""></span>cc &#40;33-49&#44;75&#41;&#46; El tratamiento fue focal y total en 64 y 21 pacientes respectivamente&#46; Diez pacientes recibieron tratamiento de rescate&#46; La tasa de complicaciones fue del 15&#37;&#44; todas Clavien 2&#46; La estancia hospitalaria media fue 1&#44;8 d&#237;as &#40;0-7&#41; y la sonda vesical fue retirada el d&#237;a 2 &#40;1-6&#41;&#46; La media de reducci&#243;n porcentual del PSA fue 54&#37;&#46; La mediana de seguimiento fue 3 meses &#40;2-8&#41;&#46; Resultados funcionales&#58; todos los pacientes estuvieron continentes a los 3 meses y la potencia se mantuvo en el 83&#37; de los previamente potentes&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">El tratamiento HIFU Focal-One<span class="elsevierStyleSup">&#174;</span> es un procedimiento seguro con pocas complicaciones&#46; Los resultados funcionales no reportan casos de incontinencia y la funci&#243;n sexual se mantuvo en el 83&#37;&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0025"
            "titulo" => "Objetivos"
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          1 => array:2 [
            "identificador" => "abst0030"
            "titulo" => "Material y m&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0035"
            "titulo" => "Resultados"
          ]
          3 => array:2 [
            "identificador" => "abst0040"
            "titulo" => "Conclusiones"
          ]
        ]
      ]
    ]
    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Perez-Reggeti JI&#44; Sanchez-Salas R&#44; Sivaraman A&#44; Linares Espinos E&#44; de Gracia-Nieto AE&#44; Barret E&#44; et al&#46; Ultrasonido focalizado de alta intensidad con el dispositivo Focal-One<span class="elsevierStyleSup">&#174;</span>&#58; impacto sobre el ant&#237;geno prost&#225;tico espec&#237;fico y evaluaci&#243;n de la morbilidad durante la experiencia inicial&#46; Actas Urol Esp&#46; 2016&#59;40&#58;608&#8211;614&#46;</p>"
      ]
    ]
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        "descripcion" => array:1 [
          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Patient positioning on Focal-One<span class="elsevierStyleSup">&#174;</span>&#46;</p>"
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      ]
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          "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Prostate-specific antigen evolution&#46;</p>"
        ]
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      2 => array:7 [
        "identificador" => "fig0015"
        "etiqueta" => "Figure 3"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr3.jpeg"
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        "descripcion" => array:1 [
          "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Contrast-enhanced ultrasound image after HIFU&#46; &#40;A&#41; Image fusion and treatment planning&#46; &#40;B&#41; Treated area control&#46;</p>"
        ]
      ]
      3 => array:7 [
        "identificador" => "fig0020"
        "etiqueta" => "Figure 4"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
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          "en" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">mpMRI image 1 month after HIFU &#40;hemiablation&#41;<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>TURP&#46; Patient 77y&#44; PSA&#58; 7&#46;5<span class="elsevierStyleHsp" style=""></span>ng&#47;ml&#59; PCa Gleason 3<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>4&#59; mpMRI&#58; 10<span class="elsevierStyleHsp" style=""></span>mm lesion 10p PIRADS 5&#47;5&#44; prostate volume 30<span class="elsevierStyleHsp" style=""></span>ml&#59; control PSA&#58; 1&#46;71<span class="elsevierStyleHsp" style=""></span>ng&#47;ml&#46;</p>"
        ]
      ]
      4 => array:8 [
        "identificador" => "tbl0005"
        "etiqueta" => "Table 1"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
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        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at1"
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        "tabla" => array:2 [
          "leyenda" => "<p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Data are median &#40;IQR&#41;&#44; number &#40;&#37;&#41; or number&#46;</p><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">BMI&#44; body mass index&#59; PSA&#44; prostate-specific antigen&#59; mpMRI&#44; multiparametric magnetic resonance imaging&#46;</p>"
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              "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">&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"><span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>85&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"><span class="elsevierStyleItalic">Age&#44; years</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">70 &#40;66&#8211;77&#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"><span class="elsevierStyleItalic">BMI&#44; kg&#47;m</span><span class="elsevierStyleSup"><span class="elsevierStyleItalic">2</span></span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">25 &#40;24&#8211;27&#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"><span class="elsevierStyleItalic">PSA diagnosis&#44; ng&#47;ml</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7&#46;79 &#40;6&#46;32&#8211;9&#46;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="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Prostate volume&#44; ml</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">38 &#40;33&#8211;49&#46;75&#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"><span class="elsevierStyleItalic">Transperineal mapping</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">85 &#40;100&#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"><span class="elsevierStyleItalic">Total cancer length&#44; mm</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7&#46;50 &#40;4&#46;25&#8211;14&#46;50&#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" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Gleason</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">52 &#40;61&#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"><span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">30 &#40;35&#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"><span class="elsevierStyleHsp" style=""></span>4<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">2 &#40;3&#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"><span class="elsevierStyleHsp" style=""></span>4<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">1 &#40;1&#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" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Tumor side</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Right&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">29 &#40;34&#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"><span class="elsevierStyleHsp" style=""></span>Left&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">43 &#40;51&#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"><span class="elsevierStyleHsp" style=""></span>Bilateral&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">13 &#40;15&#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" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Localization</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Base&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">30 &#40;35&#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"><span class="elsevierStyleHsp" style=""></span>Medial&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">20 &#40;24&#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"><span class="elsevierStyleHsp" style=""></span>Apex&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">13 &#40;15&#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"><span class="elsevierStyleHsp" style=""></span>Anterior&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">1 &#40;1&#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"><span class="elsevierStyleHsp" style=""></span>Multiple unilateral&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">8 &#40;10&#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"><span class="elsevierStyleHsp" style=""></span>Bilateral&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">13 &#40;15&#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"><span class="elsevierStyleItalic">Suspected lesion mpMRI</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">71 &#40;84&#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" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">TNM</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>cT1c&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">63 &#40;74&#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"><span class="elsevierStyleHsp" style=""></span>cT2a&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">14 &#40;17&#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"><span class="elsevierStyleHsp" style=""></span>cT2b&nbsp;\t\t\t\t\t\t\n
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Original language: English
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