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

Objectives: Enzalutamide (Xtandi, MDV3100) is a nonsteroidal, oral agent targeting the androgen receptor (AR) with a different mechanism from other AR inhibitors. This randomized, double-blind phase II trial compares enzalutamide with bicalutamide (Casodex) in asymptomatic or mildly symptomatic patients who have disease progression despite primary androgen deprivation therapy.

Key entry or exclusion criteria: Patients should have ongoing androgen deprivation therapy for recurrent prostate cancer following definitive, localized therapy with a GnRH analogue or bilateral orchiectomy.

Locations: 11 sites.

Goal: 400 patients.

Study sponsor: Medivation, Inc. in collaboration with Astellas Pharma, Inc.

Link for more information: clinicaltrials.gov/ct2/show/NCT01664923

NIH clinical trials identifier: NCT01664923