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Site for NRG-GU009, “Parallel Phase III Randomized Trials For High Risk Prostate Cancer Evaluating De-Intensification For Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation (Predict-RT*)”
This study is being done to answer the following questions: If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment? If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment? We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cancer.
This study is being done to answer the following questions: If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment? If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment? We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cance
High-risk disease
ECOG Performance Status of 0-2 within 120 days prior to registration
Adequate hematologic function within 120 days prior to registration
Adequate hepatic function within 120 days prior to registration
Prior systemic chemotherapy within ≤3 years prior to registration
Current use of 5-alpha reductase inhibitor
Didanosine (DDI) antiretroviral therapy is not permitted
History of seizure disorder or current severe or unstable angina