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
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Bicalutamide
- drug : Enzalutamide
Phase: Phase 2
Ages Eligible For Study:
- Males age 18 or older; - Histologically or cytologically confirmed adenocarcinoma of the prostate; - Ongoing androgen deprivation therapy - Serum testosterone level ? 50 ng/dL (1.73 nmol/L) at the Screening visit; - Progressive disease at study entry defined by PSA progression and/or radiographic progression that occurred while the patient was on primary androgen deprivation therapy - Asymptomatic or mildly symptomatic from prostate cancer; - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; - Estimated life expectancy of ? 12 months; - Able to swallow the study drug and comply with study requirements.