- Men with metastatic castration-resistant prostate cancer
- Progressive disease on androgen deprivation therapy
- Patients must agree to continue androgen deprivation therapy with a GnRH
agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
- ECOG performance score ≤ 1
- Estimated life expectancy of ≥ 12 months
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or
enzalutamide for the treatment of prostate cancer
- Prior participation in a clinical trial of an investigational agent that inhibits the
androgen receptor or androgen synthesis (unless the treatment was placebo)
- History of brain metastasis, active leptomeningeal disease or seizure
- Severe cardiovascular or hepatic disease
- Pituitary or adrenal dysfunction