IRB #

IRB00011268

Title

Phase II Randomized Placebo-Controlled Double-Blind Study of Salvage Radiation Therapy (SRT) Plus Placebo Versus SRT Plus Enzalutamide (MDV3100) in Men with High-Risk PSA-Recurrent Prostate Cancer after Radical Prostatectomy

Principal Investigator

Arthur Hung

Study Purpose

The purpose of this study is to compare the overall survival of two groups of patients: those randomly assigned to get the study drug(enzalutamide) plus salvage radiation therapy(SRT) and those who receive SRT plus placebo to see how effective enzalutamide is when patient are treated with SRT

Medical Condition(s)

Prostate Cancer

Eligibility Criteria

This study is for patients who have recently had a PSA recurrence following removal of their prostate (radical prostatectomy)

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

On study: 6 months. Follow-up: Up to 24 months

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Johns Hopkins University

Recruitment End

12/31/2020

Compensation Provided

No


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