A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.

Inclusion Criteria:

• Progressive prostate cancer while on androgen deprivation therapy
• Castrate testosterone level
• Maintenance of surgical or medical castration for duration of study
• Radiographically visible metastatic disease
• Symptomatic from prostate cancer
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Life expectancy >=6 months

Exclusion Criteria:

• Brain metastases or leptomeningeal disease
• Prior cytotoxic chemotherapy for prostate cancer
• Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor
• History of seizure or condition that may predispose to seizure
• History of loss of consciousness or transient ischemic attack within 12 months
• Clinically significant cardiovascular disease