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Introduction: This is the first report of a multicentre, prospective, randomized phase 3 trial to determine if multiparametric magnetic resonance imaging (mpMRI) and targeted biopsy can improve selection of patients eligible for active surveillance through improved detection of clinically significant cancer compared to systematic biopsy. The primary outcome was the proportion of subjects whose biopsy was upgraded at their confirmatory biopsy to Gleason score 7 (3 + 4) or higher. Methods: Eligible patients were diagnosed with favourable-risk prostate cancer (Gleason 6 and prostate-specific antigen [PSA] <10) within the previous 12 months. 296 patients were registered and 273 randomized between systematic 12-core biopsy and an MRI, with targeted and systematic biopsies, done between six and 13 months after the initial biopsy. There were no differences between treatment arms in terms of stratum, demographics, tumour characteristics, or prior treatments. Results: 31 (23%) of transrectal ultrasound (TRUS)-guided biopsy patients had Gleason 7 or higher cancer compared with 29 (21.2%) of the MRIguided biopsy (p=0.68). Independent, blinded pathology review was performed on 188 patients. Upgrading incorporating path review occurred in 36/132 (27.3%) of TRUS-guided and 42/127 (33.1%) of MRI-guided biopsy patients (p=0.34). The positive predictive value (PPV) for Gleason 7 or higher cancer for Prostate Imaging Reporting and Data System (PI-RADS) score 1-2, 3,4, and 5 was 13%, 29%, 24%, and 33%, respectively. 2/12 (16.7%) with a MRI score of 1, and 3/33 (9%) with MRI score of 2 had Gleason 7 or higher cancers on systematic biopsy. The negative predictive value (NPV) of PI-RADS 1-2 for Gleason ≥7 was 89%. The results of targeted vs. systematic biopsy in the MRI arm is listed in Table 1. Conclusions: No significant difference was observed in the rate of upgrading between confirmatory biopsy with TRUS compared with MRI-guided targeted biopsy. No secondary outcome was statistically significant. Performing confirmatory targeted biopsy only in men with a PI-RADS lesion ≥3 would identify 89% of Gleason 7 or greater cancers.

P1Tying the knot on robotic transition: Results of a prospective study on the learning curve and operative time of robotic pediatric urology procedures Noah Stern, Roderick Clark, Aseem Shukla, Sumit Dave Western University, London, ON, Canada Introduction: The transition to robotic-assisted procedures in pediatric urology leads to an increase in operative times, which impacts healthcare costs and resources. Attempts to reduce the learning curve of robotic surgery in adults have focused on structured training to improve operative times at each step, but this work has not extended to pediatric urology. The objectives of this study are to investigate the learning curve and operative times of a single surgeon transitioning from laparoscopic pyeloplasty to robotic-assisted pyeloplasty (RAP) and from open ureteric re-implantation to robotic-assisted extravesical ureteral re-implantation (RUR) and to determine where efficiency gains are found early in the learning curve.Methods: This prospective cohort study includes all RAP and RUR procedures performed using a three-port technique between July 2013 and April 2016. Both operations were sectioned into discrete operative steps: ports insertion and closure, dissection of the ureteropelvic junction (RAP) or ureter (RUR), dismemberment of the renal pelvis and spatulation (RAP) or creation of the submucosal tunnel (RUR), ureteropelvic anastomosis (RAP) or closure of the submucosal detrusor tunnel (RUR) recorded by a trained unbiased coder. The primary outcome was the trends of total and step-specific operative times. Success was defined as resolution or significant decrease in the grade of hydronephrosis for the RAP group and resolution of urinary tract infections off antibiotic prophylaxis or negative voiding cystourethrogram (VCUG) in the RUR group. Operative times were compared using student's t-test by the first and last quartiles. Descriptive analyses were performed on other outcomes of interest. Results: See Table 1. Conclusions: A reduction in intracorporeal suturing time leads to the greatest efficiency gain when transitioning to RAP and RUR. At our center, despite a relatively low volume of robotic cases (14/year), this efficiency was achieved within the first 20 procedures for both RAP and RUR. This study will aid the design of structured residency training programs to improve the operative learning curve for novice surgeons initiating RAP and RUR. P2Natural history and predictors of parastomal hernia after robotassisted radical cystectomy Ahmed Aly Hussein Aly, Youssef Ahmed, Paul May, Peter Loud, Taimoor Ali, Basem Ahmad, Khurshid A. Guru Roswell Park Cancer Institute, Buffalo, NY, USA Introduction: Parastomal hernia (PH) is a frequent complication of urinary diversion after radical cystectomy. We investigated the prevalence, predictors, and outcomes of PH. Clinical and radiological evidence of PH was also investigated. Methods: Retrospective review of 446 patients who underwent RARC at our institution from 2005 was conducted. Data was reviewed for demograp...

Introduction and Objectives:The phase 2 TERRAIN trial compared the efficacy and safety of enzalutamide (ENZA) vs. bicalutamide (BIC) in patients (pts) with metastatic castration-resistant prostate cancer who had progressed on luteinizing hormone-releasing hormone agonist/antagonist therapy or after bilateral orchiectomy while maintaining castration therapy during the study. An age effect analysis was pre-specified to investigate the efficacy and safety of ENZA vs. BIC. Results are presented in younger (<75 years) and older (≥75 years) pts in the TERRAIN population. Methods: In this double-blind study in North America and Europe, pts were randomized 1:1 to ENZA 160 mg/day or BIC 50 mg/day. The primary efficacy endpoint was centrally assessed progression-free survival (PFS) and a secondary efficacy endpoint was time to prostate-specific antigen (PSA) progression. Results: 184 pts were randomized to ENZA and 191 pts to BIC. 126 (68.5%) and 119 (62.3%) pts were <75, and 58 (31.5%) and 72 (37.7%) pts were ≥75, in the ENZA and BIC arms, respectively. PFS was significantly improved with ENZA vs. BIC in pts <75 years (median 16.6 vs. 5.8 months; HR 0.38 (95% CI 0.27, 0.52) and pts ≥75 years (median 13.8 vs. 6.4 months; HR 0.59 (95% CI 0.37, 0.92). Median time to PSA progression was similarly significantly improved with ENZA vs. BIC in younger (median 22.1 vs. 8.2 months; HR 0.27 (95% CI 0.18, 0.40) and older pts (median 16.6 vs. 5.8 months; HR 0.33 (95% CI 0.19, 0.57). Adverse events (AEs) with ENZA were more frequent in older pts (98.3%) vs. younger pts (92.8%), but a similar distribution of treatment-related AEs between treatment arms was observed in either age group. Conclusions: ENZA had greater efficacy than BIC regardless of age, with superior PFS and time to PSA progression. ENZA showed safety consistent with its known safety profile in both age subgroups.