BACKGROUND AND OBJECTIVE:Targeted plus perilesional biopsies are recommended for men with prostate lesions visible on magnetic resonance imaging. However, available data are mainly retrospective, without predefined biopsy scheme protocols. The MRI-Integrated Regional and targeted Approach, recommendations, and Guidelines for prostate biopsies (MIRAGE) study is the first prospective European study designed to evaluate the outcomes when perilesional biopsies are incorporated deliberately into the biopsy protocol. METHODS:MIRAGE was a prospective, observational, multicenter study conducted across ten European centers between January and June 2025. We enrolled 912 men with a single Prostate Imaging Reporting and Data System (PI-RADS) ≥3 lesion. Targeted and perilesional biopsies were mandated, while distant biopsies (ie, cores taken beyond the perilesional zone) were left to the discretion of investigators. Detection rates of Gleason grade (GG) group ≥2 and 1 lesions were calculated separately for each scheme: targeted, perilesional, and distant biopsies. KEY FINDINGS AND LIMITATIONS:Targeted biopsy detected GG group ≥2 lesions in 380 men (41%). Compared with targeted biopsy alone, perilesional sampling increased GG group ≥2 lesion detection by +3.6% at the cost of +1% GG group 1 lesion detection. The greatest benefit of perilesional sampling was observed in biopsy-naïve men and those with PI-RADS 4-5 lesions. Conversely, in those with PI-RADS 3 or a prior negative biopsy, perilesional sampling yielded more cases of GG group 1 than of GG group ≥2. Distant sampling provided minimal incremental GG group ≥2 (contralateral: +1.6%; ipsilateral: +1.4%) but more GG group 1 (contralateral: +2.5%; ipsilateral: +2.9%) cases. CONCLUSIONS AND CLINICAL IMPLICATIONS:The MIRAGE study provides prospective evidence that, when a targeted plus perilesional biopsy strategy is applied, distant biopsies add minimal diagnostic benefit and should be omitted.
BACKGROUND AND OBJECTIVE:The transperineal (TP) route is recommended for prostate biopsy due to its superior safety profile. However, randomized evidence comparing the TP and the transrectal (TR) routes was generated through combined targeted and systematic biopsy frameworks, now challenged by lesion-focused strategies, defined as the combination of targeted (TB) and perilesional (PB) sampling without distant systematic cores. This study aimed to reassess the diagnostic performance of TP versus TR biopsy with the recommended TB + PB scheme. METHODS:This prospective multicenter, observational study was conducted across 10 European institutions between January 2025 and June 2025. We included 912 men with at least one magnetic resonance imaging (MRI)-visible lesion (Prostate Imaging-Reporting and Data System version 2.1 ≥3) who underwent either TP or TR MRI-targeted biopsy according to predefined TB + PB protocols. The primary outcome was the detection rate of clinically significant prostate cancer (csPC; Gleason Grade [GG] Group ≥2). KEY FINDINGS AND LIMITATIONS:TP biopsy detected more csPC than TR (48% vs 39%; OR [odds ratio]: 1.41, 95% CI [confidence interval]: 1.06-1.88; p = 0.017) without increasing the detection of insignificant PC (insPC) (18% vs 23%; p = 0.06). In multivariable mixed-effects analysis accounting for center-level clustering, the TP route remained independently associated with csPC detection (adjusted OR: 1.61, 95% CI: 1.17-2.23; p = 0.004). Limitations include limited power in selected subgroups and potential inter-center heterogeneity inherent to the observational design. CONCLUSIONS AND CLINICAL IMPLICATIONS:Within a standardized lesion-focused TB + PB framework, TP biopsy was independently associated with higher csPC detection without increasing insPC detection. This study focuses on diagnostic performance and does not provide direct comparative data on biopsy-related complications or patient-reported outcomes.
OBJECTIVE:To assess the oncological outcomes of targeted microwave ablation (TMA) using organ-based tracking (OBT) Fusion® via KOELIS Trinity® (KOELIS, Meylan, France) in men with intermediate-risk prostate cancer (PCa): the VIOLETTE trial (ClinicalTrials.gov identifier: NCT04582656) PATIENTS AND METHOD: In this prospective phase II, multicentre European study, men with a prostate-specific antigen (PSA) level <20 ng/mL, a single magnetic resonance imaging (MRI)-visible lesion ≤15 mm, International Society of Urological Pathology (ISUP) Grade Group 2 on MRI-targeted biopsy, and clinical T stage ≤2, were enrolled. The microwave applicator was placed using OBT Fusion guidance, either transperineally or transrectally. The primary endpoint was the absence of clinically significant PCa (csPCa), defined as ISUP Grade Group ≥2, within the treated area at 12 months. Secondary endpoints included safety, functional outcomes using validated measures, and the need for subsequent radical treatment. RESULTS:A total of 76 patients were treated across six centres with 66 (87%) completing the 12-month follow-up. At 6 months, six patients had csPCa after positive MRI control, including four within the treated area. At 12 months, csPCa was detected in 15 additional patients, including nine in-field recurrences, yielding an 81% in-field csPCa-free rate. Five serious adverse events in three patients were reported. Sexual (-2.5 points; P < 0.001) and ejaculatory (-1 points; P < 0.001) scores decreased significantly, whereas urinary function remained stable. Radical treatment was required in four (5.2%) patients at 12 months. CONCLUSION:Targeted microwave ablation using OBT Fusion technology appears to be a safe and effective focal therapy procedure for localised intermediate-risk PCa. The VIOLETTE trial achieved its primary endpoint, with 81% patients free of in-field csPCa at 12 months.
AbstractObjectiveThe aim of this study was to assess the precision and safety of targeted microwave ablation (TMA) using organ‐based tracking (OBT) fusion, in patients with intermediate risk prostate cancer.Patients and methodWe conducted a prospective, multicentric trial. Eligible patients had a prostate‐specific antigen (PSA) < 20 ng/mL, a magnetic resonance imaging (MRI)‐visible index tumour of Gleason score 3 + 4, with largest axis ≤15 mm and distant of at least 5 mm from the rectum and apex. TMA was performed with microwave needle applicator using OBT fusion, with a transperineal or a transrectal approach. In this interim analysis, we evaluated precision, safety, urinary and sexual outcomes, and PSA density kinetics.ResultsAt this point, 37 patients were treated in five centres. Median (interquartile range) age is 68 (63–72) years. Baseline median prostate volume and PSA are of 45 (34–57) mL and 8 (6.2–10.8) ng/mL, respectively. Median largest tumour axis on T2W MRI is of 11 mm (10–13). Patients were treated under general anaesthesia or conscious IV sedation in an outpatient setting. Anaesthesia had a median duration of 78 (66–90) min. A median number of 3 (2–4) 12‐W ablations of 2 to 5 min were performed per patient. After a median follow‐up of 6 (2.4–10) months, we observed 58 adverse events (AE) in 22 patients. These were of Common Terminology Criteria for Adverse Events (CTCAE) grade 1, 2 and 3 in 43 (74%), 13 (22%) and 2 (4%) cases. Six (15%) patients had an acute urinary retention, five of which considered as severe AE because of rehospitalisation. We did not observe any significant difference in International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire‐ejaculatory dysfunction (MSHQ‐EjD) and International Index of Erectile Function (IIEF5) from baseline to last follow‐up. Median PSA density evolved from 0.2 (0.1–0.3) at baseline to 0.1 (0.07–0.16) at 12 months.ConclusionsThese preliminary results suggest that TMA using OBT fusion is precise and safe in patients with intermediate risk localised prostate cancer. Further inclusions and follow‐up are needed to assess oncological outcome.
Introduction When performing targeted biopsy (TBx), the need to add systematic biopsies (SBx) is often debated. Aim of the study is to evaluate the added value of SBx in addition to TBx in terms of prostate cancer (PCa) detection rates (CDR), and to test the concordance between multiparametric magnetic resonance imaging (mpMRI) findings and fusion biopsy results in terms of cancer location. Methods We performed a retrospective, multicentric study that gathered data on 1992 consecutive patients who underwent elastic fusion biopsy between 2011 and 2020. A standardized approach was used, with TBx (2-4 cores per target) followed by SBx (12-14 cores). We assessed CDR of TBx, of SBx, and TBx+SBx for all cancers and clinically significant PCa (csPCa), defined as ISUP score >= 2. CDR was evaluated according to radiological and clinical parameters, with a particular focus on PI-RADS 3 lesions. In a subgroup of 1254 patients we tested the discordance between mpMRI findings and fusion biopsy results in terms of cancer location. Uni- and multivariable logistic regression analyses were performed to identify predictors of CDR. Results CDR of TBx+SBx was 63.0% for all cancers and 38.8% of csPCa. Per-patient analysis showed that SBx in addition to TBx improved CDR by 4.5% for all cancers and 3.4% for csPCa. Patients with lesions scored as PI-RADS 3, 4, and 5 were diagnosed with PCa in 27.9%, 72.8%, and 92.3%, and csPCa in 10.7%, 43.6%, and 69.3%, respectively. When positive, PI-RADS 3 lesions were ISUP grade 1 in 61.1% of cases. Per-lesion analysis showed that discordance between mpMRI and biopsy was found in 56.6% of cases, with 710 patients having positive SBx outside mpMRI targets, of which 414 (58.0%) were clinically significant. PSA density >= 0.15 was a strong predictor of CDR. Conclusions The addition of systematic mapping to TBx contributes to a minority of per-patient diagnoses but detects a high number of PCa foci outside mpMRI targets, increasing biopsy accuracy for the assessment of cancer burden within the prostate. High PSA-density significantly increases the risk of PCa, both in the whole cohort and in PI-RADS 3 cases.
You have accessJournal of UrologyProstate Cancer: Detection & Screening III (MP30)1 Sep 2021MP30-04 IMPROVED CANCER DETECTION WITH TARGETED BIOPSIES ONLY: RESULTS FROM A MULTICENTER SERIES USING KOELIS FUSION SYSTEM Oderda Marco, Simone Albisinni, Daniel Benamran, Giorgio Calleris, Mauro Ciccariello, Alessandro Dematteis, Romain Diamand, Jean-Luc Descotes, Gaelle Fiard, Valerio Forte, Alessandro Giacobbe, Alessandro Marquis, Giancarlo Marra, Aurel Messas, Giovanni Muto, Alexandre Peltier, Leire Rius, Giuseppe Simone, Thierry Roumeguere, and Paolo Gontero Oderda MarcoOderda Marco More articles by this author , Simone AlbisinniSimone Albisinni More articles by this author , Daniel BenamranDaniel Benamran More articles by this author , Giorgio CallerisGiorgio Calleris More articles by this author , Mauro CiccarielloMauro Ciccariello More articles by this author , Alessandro DematteisAlessandro Dematteis More articles by this author , Romain DiamandRomain Diamand More articles by this author , Jean-Luc DescotesJean-Luc Descotes More articles by this author , Gaelle FiardGaelle Fiard More articles by this author , Valerio ForteValerio Forte More articles by this author , Alessandro GiacobbeAlessandro Giacobbe More articles by this author , Alessandro MarquisAlessandro Marquis More articles by this author , Giancarlo MarraGiancarlo Marra More articles by this author , Aurel MessasAurel Messas More articles by this author , Giovanni MutoGiovanni Muto More articles by this author , Alexandre PeltierAlexandre Peltier More articles by this author , Leire RiusLeire Rius More articles by this author , Giuseppe SimoneGiuseppe Simone More articles by this author , Thierry RoumeguereThierry Roumeguere More articles by this author , and Paolo GonteroPaolo Gontero More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002027.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We evaluated the accuracy of elastic fusion biopsy in different European Centers using a standardized approach with the Koelis system. Our aim was to assess the added value of systematic biopsies (SB) in addition to targeted biopsies (TB) with regard to cancer detection rate (CDR), according to PIRADS score. METHODS: We prospectively included 1.992 patients who underwent fusion biopsy with the Koelis system between 2011 and 2020 in 8 European institutions. Prostate biopsy was performed including TB (a median of 3 per target) plus SB (12 to 14 cores). CDR for all cancers and for clinically significant (cs) prostate cancer (PCa), defined as ISUP score ≥2, was evaluated. Predictors of PCa detection in TB only were assessed on uni- and multivariable analyses. RESULTS: The TB+SB CDR was 63% for all cancers and 39% for csPCa. SB in addition to TB improved the CDR by 4% for all cancers and 8% for csPCa. PCa was detected in 28%, 73% and 92% of PIRADS 3, 4 and 5 respectively (Table 1). PIRADS 3 resulted in ISUP grade 1 in over 60% of cases, while the proportion of ISUP grade 4 and 5 markedly increased only in PIRADS 5. PSA-density (HR 45.3), elevated PIRADS score (HR 12.3) and digital rectal examination (HR 1.43) were predictors of CDR in TB on multivariate analyses (Table 2). CONCLUSIONS: Koelis fusion biopsy achieves a high CDR. TB only can detect a wide majority of PCa, whilst SB contributes to a minority of diagnoses. High PSA density is a strong PCa predictor, whilst PIRADS 3 leads to PCa detection in <30% of cases, frequently clinically insignificant. Source of Funding: No funding © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e500-e500 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Oderda Marco More articles by this author Simone Albisinni More articles by this author Daniel Benamran More articles by this author Giorgio Calleris More articles by this author Mauro Ciccariello More articles by this author Alessandro Dematteis More articles by this author Romain Diamand More articles by this author Jean-Luc Descotes More articles by this author Gaelle Fiard More articles by this author Valerio Forte More articles by this author Alessandro Giacobbe More articles by this author Alessandro Marquis More articles by this author Giancarlo Marra More articles by this author Aurel Messas More articles by this author Giovanni Muto More articles by this author Alexandre Peltier More articles by this author Leire Rius More articles by this author Giuseppe Simone More articles by this author Thierry Roumeguere More articles by this author Paolo Gontero More articles by this author Expand All Advertisement Loading ...
You have accessJournal of UrologyProstate Cancer: Detection & Screening III (MP30)1 Sep 2021MP30-05 CANCER DETECTION IN PIRADS 3 LESIONS: THE ADDED VALUE OF PSA DENSITY AND ANTERIOR LOCATION Marco Oderda, Simone Albisinni, Daniel Benamran, Giorgio Calleris, Mauro Ciccariello, Alessandro Dematteis, Romain Diamand, Jean-Luc Descotes, Gaelle Fiard, Valerio Forte, Alessandro Giacobbe, Alessandro Marquis, Giancarlo Marra, Aurel Messas, Giovanni Muto, Alexandre Peltier, Leire Rius, Giuseppe Simone, Thierry Roumeguere, and Paolo Gontero Marco OderdaMarco Oderda More articles by this author , Simone AlbisinniSimone Albisinni More articles by this author , Daniel BenamranDaniel Benamran More articles by this author , Giorgio CallerisGiorgio Calleris More articles by this author , Mauro CiccarielloMauro Ciccariello More articles by this author , Alessandro DematteisAlessandro Dematteis More articles by this author , Romain DiamandRomain Diamand More articles by this author , Jean-Luc DescotesJean-Luc Descotes More articles by this author , Gaelle FiardGaelle Fiard More articles by this author , Valerio ForteValerio Forte More articles by this author , Alessandro GiacobbeAlessandro Giacobbe More articles by this author , Alessandro MarquisAlessandro Marquis More articles by this author , Giancarlo MarraGiancarlo Marra More articles by this author , Aurel MessasAurel Messas More articles by this author , Giovanni MutoGiovanni Muto More articles by this author , Alexandre PeltierAlexandre Peltier More articles by this author , Leire RiusLeire Rius More articles by this author , Giuseppe SimoneGiuseppe Simone More articles by this author , Thierry RoumeguereThierry Roumeguere More articles by this author , and Paolo GonteroPaolo Gontero More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002027.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: According to the literature, PIRADS 3 lesions are associated with prostate cancer (PCa) in 30 to 50% of cases. Our aim was to assess the cancer detection rate (CDR) of elastic fusion biopsy in patients with a diagnosis of PIRADS 3 at multi-parametric MRI, focusing on the predictive value of PSA density (PSA-d) and target location. METHODS: Data of 1,992 patients who underwent fusion biopsy with Koelis system, receiving target biopsy (TB, a median of 3 per target) plus systematic biopsy (SB, 12 to 14 cores) were prospectively collected. Among them, a subgroup of 578 men diagnosed with PIRADS 3 lesions only was selected. CDR for all PCa and clinically significant PCa (csPCa), defined as ISUP score ≥2, was assessed. The role of PSA-d and target location (anterior or transitional) was evaluated in uni- and multivariable analyses. RESULTS: CDR of PIRADS 3 was 28% for all cancers and 10.7% for csPCa; in these patients the added value of SB was low (3.9%). PSA-d >0.15 and the anterior location of PIRADS 3 lesions increased CDR to 39.9% (18.1% for csPCa) and to 55.2% (17.2% for csPCa) respectively (Table 1). Both in uni- and multivariable analyses, PSA-d >0.15 (HR 56.6) and anterior location (HR 2.49) were strong predictors of CDR, whilst previous negative biopsy status was associated to reduced risk of PCa (HR 0.56) (Table 2). CONCLUSIONS: The detection rate of PCa for PIRADS 3 lesions is lower than 30%, with clinically insignificant PCa findings in the majority of cases. The concomitant presence of a PSA-d >0.15 or an anterior location significantly increases the risk of PCa diagnosis. Source of Funding: No funding © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e501-e501 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Marco Oderda More articles by this author Simone Albisinni More articles by this author Daniel Benamran More articles by this author Giorgio Calleris More articles by this author Mauro Ciccariello More articles by this author Alessandro Dematteis More articles by this author Romain Diamand More articles by this author Jean-Luc Descotes More articles by this author Gaelle Fiard More articles by this author Valerio Forte More articles by this author Alessandro Giacobbe More articles by this author Alessandro Marquis More articles by this author Giancarlo Marra More articles by this author Aurel Messas More articles by this author Giovanni Muto More articles by this author Alexandre Peltier More articles by this author Leire Rius More articles by this author Giuseppe Simone More articles by this author Thierry Roumeguere More articles by this author Paolo Gontero More articles by this author Expand All Advertisement Loading ...
You have accessJournal of UrologyProstate Cancer: Detection & Screening V (PD50)1 Sep 2021PD50-09 MRI AND BIOPSY AGREEMENT IN DEFINING PROSTATE CANCER LOCATION: A MULTICENTER STUDY Marco Oderda, Simone Albisinni, Daniel Benamran, Giorgio Calleris, Mauro Ciccariello, Alessandro Dematteis, Romain Diamand, Jean-Luc Descotes, Gaelle Fiard, Valerio Forte, Alessandro Giacobbe, Alessandro Marquis, Giancarlo Marra, Aurel Messas, Giovanni Muto, Alexandre Peltier, Leire Rius, Giuseppe Simone, Thierry Roumeguere, and Paolo Gontero Marco OderdaMarco Oderda More articles by this author , Simone AlbisinniSimone Albisinni More articles by this author , Daniel BenamranDaniel Benamran More articles by this author , Giorgio CallerisGiorgio Calleris More articles by this author , Mauro CiccarielloMauro Ciccariello More articles by this author , Alessandro DematteisAlessandro Dematteis More articles by this author , Romain DiamandRomain Diamand More articles by this author , Jean-Luc DescotesJean-Luc Descotes More articles by this author , Gaelle FiardGaelle Fiard More articles by this author , Valerio ForteValerio Forte More articles by this author , Alessandro GiacobbeAlessandro Giacobbe More articles by this author , Alessandro MarquisAlessandro Marquis More articles by this author , Giancarlo MarraGiancarlo Marra More articles by this author , Aurel MessasAurel Messas More articles by this author , Giovanni MutoGiovanni Muto More articles by this author , Alexandre PeltierAlexandre Peltier More articles by this author , Leire RiusLeire Rius More articles by this author , Giuseppe SimoneGiuseppe Simone More articles by this author , Thierry RoumeguereThierry Roumeguere More articles by this author , and Paolo GonteroPaolo Gontero More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002072.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Multiparametric MRI is nowadays paramount for prostate cancer (PCa) diagnosis and local staging. When choosing between focal or radical treatment, however, MRI accuracy in detecting all PCa foci within the gland has been questioned. In this multicenter European study, the agreement between MRI findings and fusion biopsy results is presented. METHODS: From a prospective multicenter cohort of 1.992 patients undergoing fusion biopsy using Koelis system, we extracetd a subgroup of 1.254 patients with positive findings for PCa and available tumor location data. Patients underwent target biopsy (a median of 3 cores per target) and random mapping (12 to 14 cores), Agreement in defining cancer location between regions of interest (ROI) at MRI and fusion biopsy was calculated. Clinically significant PCa (csPCa) was defined as ISUP ≥2. RESULTS: We included 1.254 PCa cases. Exact correspondence between MRI and biopsy occurred in 544 cases (43.4%). When considering also systematic cores in addition to target biopsy, cancer detection rate per patient showed a 4%-improvement for all cancers, but PCa was detected in locations outside those described at MRI in 710 (56.6%) patients (Table 1). Similar results were obtained when focusing only on csPCa (n 772): perfect agreement was found in 336 cases (43.5%). Overall, systematic biopsies yielded 476 csPCa diagnoses (37.9%), 79% of which were located outside the ROI. PIRADS score of ROI had no impact on agreement between MRI and biopsy. CONCLUSIONS: The agreement between MRI findings and cancer location on biopsy is still sub-optimal, with a large proportion of PCa and csPCa foci found outside MRI-positive area. These data support the added value of the systematic sampling in addition to targeted biopsies, especially when considering focal treatment. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e855-e855 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Marco Oderda More articles by this author Simone Albisinni More articles by this author Daniel Benamran More articles by this author Giorgio Calleris More articles by this author Mauro Ciccariello More articles by this author Alessandro Dematteis More articles by this author Romain Diamand More articles by this author Jean-Luc Descotes More articles by this author Gaelle Fiard More articles by this author Valerio Forte More articles by this author Alessandro Giacobbe More articles by this author Alessandro Marquis More articles by this author Giancarlo Marra More articles by this author Aurel Messas More articles by this author Giovanni Muto More articles by this author Alexandre Peltier More articles by this author Leire Rius More articles by this author Giuseppe Simone More articles by this author Thierry Roumeguere More articles by this author Paolo Gontero More articles by this author Expand All Advertisement Loading ...
Background and Purpose: Treatment of patients with prostate cancer has evolved considerably in the last decade, especially in terms of minimization of the negative impacts on erectile function and continence to ensure good quality of life for treated patients. New surgical devices, such as dissectors and hemostatic scalpels, allow precise definition of the surgical field with finer dissection of the anatomic structures, with subsequent reductions in operative times and better oncologic and functional outcomes. Although monopolar scissors (MS) are still widely used, radiofrequency (RF) and ultrasound (US) scalpels have been introduced recently in laparoscopic radical prostatectomy (LRP). Despite the widespread use of these scalpels, however, few studies have compared these devices in terms of oncologic and functional outcomes after radical prostatectomy. The present study aimed to prospectively assess the impact of MS, RF, and US scalpels on margin status at apex, and recovery of urinary continence and erectile function in patients undergoing extraperitoneal LRP. Patients and Methods: A total of 150 men were prospectively enrolled between September 2009 and April 2013 and postoperatively evaluated for continence and clinical factors. Results: There were no differences in terms of operative times (P=0.9433), blood loss (P=0.9681), apical margin positivity (P=0.3965) or postoperative hospital stay (P=0.9257) among the groups. Moreover, no differences in the functional outcome scores, as evaluated by the International Consultation on Incontinence self-administered Questionnaire, at 1, 3, and 6 months postsurgery were observed. Conclusion: Our study represents the first evaluation of continence recovery in LRP with respect to different devices used for prostatic apex dissection. We found that the oncologic, functional, and operative outcomes were similar between these different devices during LRP, with no scalpel demonstrating superiority in continence recovery.
Purpose: Some studies imply that increasing the number of prostate biopsy cores may improve the cancer detection rate. We performed a prospective study to evaluate pain and morbidity after an extensive transrectal ultrasound guided 10-core biopsy protocol.Materials and Methods: A total of 289 consecutive men with abnormal digital rectal examination findings and/or increased prostate specific antigen underwent extensive prostate biopsy involving 6 sextant and 4 peripheral biopsies. Each received an information leaflet a few days before the procedure. A single dose of fluoroquinolone and a rectal enema were administered before biopsy. In no case was the procedure performed using anesthesia. Immediately after biopsy patients were asked to complete a self-administered nonvalidated questionnaire evaluating the degree of pain and/or discomfort using a visual analog scale. In another questionnaire they listed the side effects noticed during month 1 after biopsy.Results: Although 48% of the 275 men who completed the initial questionnaire reported anxiety before the procedure, 78.8% of them were completely reassured by the information brochure. Of the 275 patients 47.6% described the procedure as painful, including only slightly painful (analog visual scale 3 or less) in 67.9%, while 33.8% described it as uncomfortable but not painful and 18.6% thought that it was neither painful nor uncomfortable. Of the 115 patients who engaged in sexual intercourse during month I after the procedure 78.3% noticed hematospermia an average of 10.9 days in duration. Of the 164 men who completed questionnaire 2, 74.4% noticed hematuria an average of 2.7 days in duration, 3.7% noticed pyrexia and 1.2% noticed acute prostatitis. In the 59 patients (36%) who reported delayed perineal pain it was slight in 64.4%, moderate in 30.5% and severe in 5.1%. No patient required hospitalization.Conclusions: Although minor complications are common, the extensive 10-core prostate biopsy protocol is associated with few major complications. The occurrence and intensity of pain and discomfort are in the range reported after the standard 6-core biopsy protocol.