Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer (STRIVE)

The purpose of this study is to determine the safety and efficacy of enzalutamide vs. bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Phase 2, Randomized, Double-Blind, Efficacy and Safety Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer Who Have Failed Primary Androgen Deprivation Therapy
Enrollment: 396
Study Start Date: July 2012
Estimated Study Completion Date: June 2018
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Enzalutamide
- Active Comparator: Bicalutamide