A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of Enzalutamide (MDV3100) in Patients With Hormone-naïve Prostate Cancer

To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.

Inclusion Criteria:

• Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
• Asymptomatic from prostate cancer
• Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
• PSA ≥ 2 ng/mL at screening

Exclusion Criteria:

Has previously or is currently receiving:

• Hormonal therapy with intent to treat prostate cancer
• Systemic glucocorticoids
• Chemotherapy with the intent to treat prostate cancer
• Opiate analgesics for pain from prostate cancer
• Radiation therapy for treatment of the primary tumor or metastases
• Has history of known or suspected brain or skull metastases or leptomeningeal disease
• Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
• Clinically significant cardiovascular disease