Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer

PRIMARY OBJECTIVES: I. To determine the incidence of metabolic syndrome within 12 months, as defined by the Adult Treatment Panel III, in patients treated with enzalutamide compared to standard androgen deprivation therapy. SECONDARY OBJECTIVES: I. To determine the incidence of metabolic syndrome within 6 months, as defined by the Adult Treatment Panel III, in patients treated with enzalutamide compared to standard androgen deprivation therapy. II. To assess bone health, as measured by a dual-energy x-ray absorptiometry (DXA) scanner. III. To assess body composition (sarcopenic obesity), as measured by a DXA scanner. IV. To assess quality of life (QOL), as measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Sexual Health Inventory in Men (SHIM). V. To assess time to prostate-specific antigen (PSA) progression and time to radiographic progression. VI. To assess the incidence of developing individual risk factors, or components, which comprise metabolic syndrome. VII. To assess the change in high-sensitivity C-reactive protein (hs-CRP) as a marker of inflammation. VIII. To assess the safety and tolerance of enzalutamide or androgen deprivation therapy (ADT). IX. To assess the change in physical function as measured by the Short Physical Performance Battery (SPPB). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive enzalutamide orally (PO) once daily (QD) for 12 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. After completion of study treatment, patients are followed up at 30 days.