Conditions: Prostate Cancer
Keywords: Progressive Metastatic Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1717
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Enzalutamide intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal. intervention 2: Participants received placebo, administered as four capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.

Protocol document: