Background: Phase III, Double blinded, RCT included 1,199 patients with metastatic, castration-resistant prostate cancer after one or two chemotherapy regimens.

Arm A: Enzalutamide 160 mg daily
Arm B: Placebo

Primary Endpoint: OS
mFollow up: 14.4 mo

OS: 18.4 mo vs 13.6 mo, arm A vs B; HR 0.63, 95% CI 0.53-0.75; P<.001

Secondary endpoints: PSA-level response rate (54% vs 2%, P<0.001), soft-tissue response rate (29% vs 4%, P<0.001), quality-of-life response (43% vs 18%, P<0.001), the time to PSA progression (8.3mo vs 3.0mo; P<0.001), radiographic PFS (8.3mo vs. 2.9mo; P<0.001)

Main Adverse events: Grade 3-4 events (45.3% vs 53.1% arm A vs B). Most common: Fatigue (34% vs 29%), Diarrhea (21% vs 18%), Hot flash (20% vs 10%), musculoskeletal pain (14% vs 10%), seizure (0.6% vs 0%)

Conclusions: Enzalutamide improved OS, PSA response rate, quality of life response, time to PSA progression, soft tissue response rate, radiographic PFS, time to first skeletal related event when compared to placebo in men with metastatic, castration resistant prostate cancer.

Summarized by Pragnan Kancharla, MD

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