A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Non-metastatic Prostate Cancer Progressing After Definitive Therapy
A study for men with non-metastatic prostate cancer using study drugs enzalutamide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide
Sponsor: Medivation
Enrolling: Male and Female Patients
IRB Number: AAAP8857
U.S. Govt. ID: NCT02319837
Contact: Sven Wenske: 212-305-6408 / sw2510@cumc.columbia.edu
Additional Study Information: This study will enroll participants with prostate cancer that were treated by removing the prostate or by giving radiation (or both), but whose blood prostate specific antigen (PSA) level is going up. PSA is produced by the prostate and other tissues, and when it goes up, it means that the prostate cancer is coming back. In this study, participants will take 4 enzalutamide or 4 placebo (contains no drug) capsules by mouth once each day. Enzalutamide is an androgen receptor inhibitor that works by blocking the action of the male hormone testosterone and other male hormones called androgens to slow down the growth of prostate cancer. Enazalutamide is approved in the United States (US) by the Food and Drug Administration (FDA) for men with advanced or metastatic castration resistant prostate cancer.
This study is closed
Richard Carvajal, MD
Do You Qualify?
Have you been diagnosed with prostate cancer? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Sven Wenske