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

This study is being done to answer the following questions: If a patient has unfavorable intermediate risk prostate cancer, a low gene risk score and plans to receive radiation therapy with hormone therapy, is radiation therapy alone as effective at controlling the cancer compared to the usual combination of radiation and hormone therapy? If a patient has unfavorable intermediate risk prostate cancer, a higher gene risk score and plans 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 the 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 specific types of prostate cancer. The usual approach for patients who are not in a study is treatment with radiation therapy alone or in combination with hormonal drugs, approved by the Food and Drug Administration (FDA), and radiation therapy. For patients who get the usual approach for this cancer, about 80 out of 100 are free of cancer after 5 years.

Are you Eligible? (Inclusion Criteria)

• Are you 18 years of age or older? Have you been diagnosed with prostate cancer, and have had no prior hormonal therapy or pelvic radiotherapy? Are you willing to make regularly scheduled visits to the clinic for treatment and evaluation?