[NCI CIRB] NRG-GU010 (GUIDANCE) - Parallel Phase III Randomized Trials of Genomic Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation
The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness.
From there it will look to answer if radiation therapy alone is as effective at controlling cancer compared to the usual combination of radiation and hormone therapy in patients with unfavorable intermediate risk prostate cancer and a lot gene risk score.
Also, if 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 in patients with unfavorable intermediate risk prostate cancer and a higher gene risk score.
This study is being done to find out how these approaches are better, similar, or worse than the usual approach for prostate cancer.
Decipher risk score / Gene risk score
Key eligibility criteria:
1. Biopsy(+) prostate adenocarcinoma within 270 days prior to registration
2. No prior hormonal therapy or pelvic radiotherapy
3. Unfavorable intermediate risk prostate cancer
18 - 100
Healthy Volunteers Needed
Duration of Participation
Knight Cancer Institute Clinical Trials
NIH Natl Cancer Inst