You have accessJournal of UrologyBladder Cancer: Invasive I1 Apr 20121405 RESULTS FROM A RANDOMIZED CONTROLLED STUDY OF PROSTATE CAPSULE SPARING (PCS) VERSUS NERVE SPARING (NS) CYSTECTOMY AND ORTHOTOPIC NEOBLADDER FOR UROTHELIAL CANCER Alon Weizer, Cheryl Lee, Khaled Hafez, Jeffrey Montgomery, James Montie, Jean Humrich, Stephanie Daignault, Brent Hollenbeck, and David Wood Alon WeizerAlon Weizer Ann Arbor, MI More articles by this author , Cheryl LeeCheryl Lee Ann Arbor, MI More articles by this author , Khaled HafezKhaled Hafez Ann Arbor, MI More articles by this author , Jeffrey MontgomeryJeffrey Montgomery Ann Arbor, MI More articles by this author , James MontieJames Montie Ann Arbor, MI More articles by this author , Jean HumrichJean Humrich Ann Arbor, MI More articles by this author , Stephanie DaignaultStephanie Daignault Ann Arbor, MI More articles by this author , Brent HollenbeckBrent Hollenbeck Ann Arbor, MI More articles by this author , and David WoodDavid Wood Ann Arbor, MI More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1856AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Radical cystoprostatectomy and orthotopic diversion is associated with urinary and sexual dysfunction. Case series suggest improved functional outcomes in patients undergoing NS or PCS cystectomy. We performed a prospective phase II trial evaluating functional/oncologic outcomes in patients undergoing these approaches. METHODS From 8/2007-11, patients with ≤cT2 bladder cancer opting for cystectomy and orthotopic diversion were randomized to PCS or NS. Eligible patients had negative 12-core prostate and prostatic urethral biopsies. The primary endpoint was 12-month urinary function score, measured by the Bladder Cancer Index (BCI). Secondary endpoints included 12-month sexual function score (per BCI), pathologic outcomes, complications and 2-year disease specific survival. RESULTS Forty of 90 patients enrolled with 37 evaluable for the primary endpoint (18 randomized to PCSC; 19 to NSC). Median follow up time is 1.5 years. Table 1 summarizes study outcomes. No statistical difference was observed in urinary and sexual function domains from baseline to 12 months; however, PCS patients appeared to recover function closer to baseline and over a shorter time period than NSC. There was no positive bladder or urethral margins. Prostate cancer (PC) and urothelial carcinoma (UC) in the urethra were detected in 11 and 6 patients, respectively despite negative preoperative biopsies. There were no urothelial recurrences and highest PSA was 0.2 in the patients with PC. Disease specific survival and 90 day Grade 3 Clavien complication were similar between groups. The planned interim analysis revealed a low probability of detecting a future statistically significant difference in the primary endpoint and the study was closed to accrual. Table 1. Demographic, Functional and Oncologic Outcomes Variable Nerve sparing (n=19) Prostate Capsule Sparing (n=18) p-value Age (mean, SD) 58.4±5.8 58.6±9.9 0.94 ECOG performance status (median, range) 0(0-1) 0 0.6 Body mass index (mean, SD) 30.9±4.3 30.4±5.6 0.76 Neo-adjuvant chemotherapy (n, %) 9(47%) 7(39%) 0.6 Clinical stage (n, %) 0.45 Ta/Tis 1(5%) 2(11%) T1 4(21%) 7(39%) T2 13(68%) 9(50%) Robotic approach (n, %) 6(32%) 4(22%) 0.71 Pathologic stage (n, %) 0.53 T0 7(37%) 6(33%) Ta/Tis 2(11%) 6(33%) T1 4(22%) 3(17%) T2 2(11%) 1(6%) T3 4(22%) 2(12%) Node positive (n,%) 5(26%) 2(11%) Lymph nodes removed (mean, SD) 16.3±7.7 16.3±9.1 0.99 Change in urinary function domain from baseline at 12 months (mean, SD) −28.9±33.9 −14.6±31.4 0.15 Change in sexual function domain from baseline at 12 months (mean, SD) −15.8±40.7 −2.1±11.2 0.22 Prostate cancer (n, %) 8(42%) 3(17%) 0.09 Urothelial cancer in urethra (n, %) 4(21%) 2(11%) 0.66 90 day major complications (n, %) 12(63%) 7(39%) 0.14 SD, standard deviation; ECOG, eastern cooperative oncology group CONCLUSIONS Patients undergoing PCS may have a clinically relevant, although not statistically significant, earlier functional recovery to baseline than patients undergoing NS, without compromising oncologic outcomes. However, neither transrectal nor transurethral biopsy confidently detect PC or urethral UC raising concerns of future sequelae, particularly in younger patients treated with PCS. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e570-e571 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alon Weizer Ann Arbor, MI More articles by this author Cheryl Lee Ann Arbor, MI More articles by this author Khaled Hafez Ann Arbor, MI More articles by this author Jeffrey Montgomery Ann Arbor, MI More articles by this author James Montie Ann Arbor, MI More articles by this author Jean Humrich Ann Arbor, MI More articles by this author Stephanie Daignault Ann Arbor, MI More articles by this author Brent Hollenbeck Ann Arbor, MI More articles by this author David Wood Ann Arbor, MI More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...