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*)

Brief description of study

In this study, patients are divided into two groups based on their Decipher score, which helps determine their risk level. High-risk patients, with a Decipher score above 0.85 or positive nodal status, will be split into smaller groups based on their treatment type and randomly assigned to either standard care or standard care plus a drug called apalutamide. Lower-risk patients, with a Decipher score of 0.85 or less, will also be split into smaller groups and randomly assigned to either standard care or radiation plus 12 months of hormone therapy. The goal for high-risk patients is to see if the new treatment is better than standard care. For lower-risk patients, the goal is to see if the new treatment is just as good as standard care. Both groups will be analyzed to see how many patients are alive without the cancer spreading, which is the primary goal. Other goals include looking at overall survival, cancer-specific death, PSA levels, time to recovery of testosterone, and side effects. They will also look at things like body weight and use of imaging tests, and how the treatments affect patients' quality of life, depression, fatigue, and cognitive abilities.




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