Spots Global Cancer Trial Database for Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
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Trial Identification
Brief Title: Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
Official Title: Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
Study ID: NCT02057939
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Contact Details
Name: Andrew Armstrong, MD ScM FACP
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
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