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 Design:||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|
- Progression Free Survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- PSA Response [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- Time to Radiographic Progression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Functional Assessment of Cancer Therapy - Prostate (FACT-P) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Composite of Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Safety will be assessed by adverse events (AEs), frequency of study drug discontinuation due to AEs, laboratory evaluations and vital signs
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2018|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Enzalutamide 160 mg/day orally
160 mg, daily, by mouth.
Active Comparator: Bicalutamide
50 mg/day orally
50 mg, daily, by mouth
Other Name: Casodex
This study is a multicenter Phase 2, randomized, double-blind, efficacy and safety study of enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate cancer who have serologic and/or radiographic disease progression despite primary androgen deprivation therapy.
Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.
An open-label period has been added to the main protocol. Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to unblinding will be offered the opportunity to receive open label enzalutamide treatment under this protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664923
Show 71 Study Locations
|Study Director:||Fong Wang, MD, PhD||Medivation, Inc.|