You have accessJournal of UrologyPlenary Session II – Late Breaking Abstracts1 Apr 2015PII-LBA10 A MULTICENTER PHASE 2 STUDY OF ENZALUTAMIDE (ENZA) VERSUS BICALUTAMIDE (BIC) IN MEN WITH NONMETASTATIC (M0) OR METASTATIC (M1) CASTRATION-RESISTANT PROSTATE CANCER (CRPC): THE STRIVE TRIAL David Penson, Andrew Armstrong, Raoul Concepcion, Neeraj Agarwal, Fong Wang, Kenneth Wu, Andree Amelsberg, De Phung, and Celestia Higano David PensonDavid Penson More articles by this author , Andrew ArmstrongAndrew Armstrong More articles by this author , Raoul ConcepcionRaoul Concepcion More articles by this author , Neeraj AgarwalNeeraj Agarwal More articles by this author , Fong WangFong Wang More articles by this author , Kenneth WuKenneth Wu More articles by this author , Andree AmelsbergAndree Amelsberg More articles by this author , De PhungDe Phung More articles by this author , and Celestia HiganoCelestia Higano More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.03.124AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail BACKGROUND ENZA, an androgen receptor inhibitor, improves overall survival vs placebo in metastatic CRPC (Scher et al 2012; Beer et al 2014). BIC 50 mg/day is a commonly used therapy in men who progress despite castrate levels of testosterone. The Phase 2 STRIVE trial (NCT01664923) compared ENZA vs BIC in men with progressive M0 or M1 CRPC to evaluate the comparative effectiveness of these agents in both populations. METHODS STRIVE was a randomized, double-blind trial that enrolled men in the US to either ENZA 160 mg/day or BIC 50 mg/day. The primary endpoint was progression free survival (PFS), defined as time from randomization to radiographic progression, PSA progression, or death from any cause, whichever occurred first. RESULTS A total of 396 men were enrolled; 198 men were randomized to each of the ENZA and BIC arms. Baseline characteristics were comparable between groups. For all patients (pts), median age was 73 years; 35% were M0 and 65% were M1; median baseline PSA was 12. Median time on treatment with ENZA was 14.7 months (mos) vs 8.4 mos with BIC. For ENZA vs BIC, respectively: median PFS was 19.4 vs 5.7 mos (HR 0.24; CI 0.18-0.32; p<0.0001); median rPFS was not reached (NR) vs 11.2 mos (HR 0.3; CI 0.21-0.44); median time to PSA progression was NR vs 8.3 mos (HR 0.19; CI 0.14-0.26; p<0.0001); PSA response ≥50% was 81.3% vs 31.3% (p<0.0001). Efficacy data by status M0 vs M1 is shown in table. Serious adverse events (AEs) and ≥3 grade cardiac AEs were similar: 29.4% and 5.1% ENZA vs 28.3% and 4.0% in BIC, respectively. One seizure was reported with ENZA. Common (≥10%) AEs reported more frequently with ENZA vs BIC were (in %): fatigue (37.6 vs 28.3), back pain (17.8 vs 15.7), hot flush (15.7 vs 9.6), fall (13.7 vs 8.1), hypertension (12.2 vs 5.1), dizziness (12.2 vs 7.1), decreased appetite (11.7 vs 8.6). CONCLUSIONS In men with either M0 or M1 CRPC, treatment with ENZA demonstrated significantly superior PFS, rPFS, time to PSA progression, and PSA response rates compared with BIC. The safety profile of ENZA was consistent with that seen in previous studies of men with mCRPC. The STRIVE study was the first head-to-head trial of antiandrogen therapy that included men with M0 CRPC. Endpoints: M0 M1 ENZA (N=70) BIC (N=69) ENZA (N=128) BIC (N=129) Median PFS (months) NR 8.6 16.5 5.5 HR (95% CI) 0.24 (0.14-0.42) 0.24 (0.17-0.34) Median radiographic PFS (months) NR NR NR 8.3 HR (95% CI) 0.24 (0.10-0.56) 0.32 (0.21-0.50) Median Time to PSA Progression (months) NR 11.1 24.9 5.7 HR (95% CI) 0.18 (0.10-0.34) 0.19 (0.13-0.28) PSA Response (≥50%) 90.9% 42.0% 76.2% 25.4% CI=confidence interval; HR=hazard ratio; NR=not reached; PSA=prostate-specific antigen © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e499 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information David Penson More articles by this author Andrew Armstrong More articles by this author Raoul Concepcion More articles by this author Neeraj Agarwal More articles by this author Fong Wang More articles by this author Kenneth Wu More articles by this author Andree Amelsberg More articles by this author De Phung More articles by this author Celestia Higano More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...