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

• Status: Completed
• Trial end date: 2013-11-30
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivation, Inc.; Pfizer
• Collaborators: Astellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
• Treatments: Dutasteride; Leuprolide

Criteria

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