Conditions: Prostatic Neoplasms
Keywords: Metastatic MDV3100 Prostate progressive Cancer enzalutamide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 375
Healthy volunteers: no

Brief summary:
The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.

Detailed description:
An open-label period was added to the main protocol. Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over bicalutamide as assessed by the primary endpoint, all ongoing enzalutamide treated participants and ongoing or previous bicalutamide treated participants that met entry criteria were offered open-label enzalutamide at the discretion of the participant and study investigators.

Arms:
arm 1: Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy. arm 2: Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Interventions: intervention 1: enzalutamide intervention 2: bicalutamide
Intervention descriptions: intervention 1: capsules intervention 2: tablets

Protocol document: