Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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