At a glance
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Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
In Brief
A Phase 2 clinical trial evaluating enzalutamide, Androgen Deprivation, and 1 other intervention for Prostate Cancer. Completed, enrolled 38 participants across 3 sites.
Detailed Summary
The purpose of this study is to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy (ADT) with salvage radiation therapy. Eligible men will have recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of 0.2 - 4 in the absence of metastatic disease on CT and bone scans. In addition to standard ADT and radiation therapy, research participants will take enzalutamide once daily for six months. It is primarily hypothesized the 2 year PFS rate will be improved with the combined therapy compared to the historical control data in a similar patients setting.
Study Details
Timeline
Interventions
160 mg orally once daily for six months
Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy