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*)
Objective
Primary Objective De-Intensification Study: To determine whether men with NCCN high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (< 0.85) can be treated with 12 months ADT plus RT instead of 24 months ADT+RT and experience non-inferior metastasis-free survival.
Intensification Study: To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk (>0.85) or have node-positive disease by conventional imaging (MRI or CT scan) will have a superior metastasis-free survival (MFS) through treatment intensification with apalutamide and abiraterone acetate with prednisone added to the standard of RT plus 24 month ADT.
Secondary Objectives for both De-Intensification and Intensification Studies To compare overall survival (OS) between the standard of care (RT plus 24 months of ADT) and either the de-intensification (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone).
To compare time to PSA failure or start of salvage treatment between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone).
To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 24 months of ADT) and either the de- intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone).
To compare MFS judged based on either standard or molecular imaging between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone).
To compare prostate cancer-specific mortality between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone).
To compare testosterone levels at the time of PSA failure and metastases between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone).
To compare time to testosterone recovery (defined as a T>200) between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone).
To compare adverse events, both clinician-reported using CTCAE v5.0 and patient- reported using PRO-CTCAE items, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone).
