Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy with or without Adjuvant Docetaxel

Protocol No
NRG-GU002
Principal Investigator
Colleen Lawton
Phase
II/III
Summary
The purpose of this study is to compare any good and bad effects of using docetaxel along with the radiation therapy and hormone suppression therapy to using radiation and hormone suppression therapy alone in men with a high chance of prostate cancer recurrence after surgically removing the prostate. Docetaxel is FDA-approved for prostate cancer that has spread and does not respond to hormone suppression. In this study, docetaxel is being used off-label. Off-label means that the FDA has not yet approved docetaxel for this type of prostate cancer that has not spread. The addition of docetaxel to the usual radiation and hormone suppression therapy could shrink your cancer or prevent it from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study approach should decrease the chance of your cancer progressing by 30% or more compared to the usual approach. There will be about 612 men taking part in this study.
Description
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
Participating Institutions
Community Memorial Hospital
Froedtert Hospital
St. Joseph's Hospital - West Bend
Status
OPEN TO ACCRUAL
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