Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Protocol No
NRG-GU010-GUIDANCE
Phase
III
Summary

This study is being done to answer the following questions:

If you have unfavorable intermediate risk prostate cancer, a low gene risk score and plan to receive radiation therapy with hormone therapy, is radiation therapy alone as effective at controlling your cancer compared to the usual combination of radiation and hormone therapy?

If you have unfavorable intermediate risk prostate cancer, a higher gene risk score and plan to receive radiation therapy with hormone therapy, does adding another new hormone therapy drug to the usual combination of radiation and hormone therapy 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 how 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.

Description
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score
Participating Institutions
Drexel Town Center
Froedtert Hospital
Status
OPEN TO ACCRUAL