Conditions: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 509
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

Detailed description:

Arms:
arm 1: Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily arm 2: Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily.

Interventions: intervention 1: Enzalutamide intervention 2: Abiraterone intervention 3: Placebo for Enzalutamide intervention 4: Prednisone
Intervention descriptions: intervention 1: 160 mg by mouth once daily intervention 2: 1000 mg by mouth once daily intervention 3: Sugar pill manufactured to mimic Enzalutamide 40 mg capsule intervention 4: 5 mg by mouth twice daily

Protocol document: