Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

A Randomized, Open-label, Phase 2 Study Of Mdv3100 As A Neoadjuvant Therapy For Patients Undergoing Prostatectomy For Localized Prostate Cancer

The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.

Inclusion Criteria:

• Willing to provide informed consent
• 18 years of age or older
• Histologically confirmed adenocarcinoma of the prostate
• Must be a candidate for radical prostatectomy and considered surgically resectable

Exclusion Criteria:

• Stage T4 prostate cancer by clinical or radiologic evaluation
• Treatment with an investigational agent within 4 weeks prior to randomization
• Received therapy for other neoplastic disorders within 5 years
• Hypogonadism or severe androgen deficiency