Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)

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.

Timeline

Start

2014-04

Primary completion

2018-03-02

Completion

2019-06-05

Publications

• Bitting RL, Healy P, George DJ, Anand M, Kim S, Mayer T, Winters C, Riggan C, Rasmussen J, Wilder R, Stein M, Frizzell B, Harrison MR, Zhang T, Lee WR, Wu Y, Koontz BF, Armstrong AJ. Phase II Trial of Enzalutamide and Androgen Deprivation Therapy with Salvage Radiation in Men with High-risk Prostate-specific Antigen Recurrent Prostate Cancer: The STREAM Trial. Eur Urol Oncol. 2021 Dec;4(6):948-954. doi: 10.1016/j.euo.2020.01.005. Epub 2020 Feb 13.

Drugs

Indications