Two Studies for Patients With High 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 High Gene Risk Score, The PREDICT-RT Trial
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*)
Sponsor: NRG Oncology + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Metastasis-free survival (MFS)
Time frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years
Sexual quality of life (De-intensification study)
Time frame: Up to 13 years
Hormonal quality of life (De-intensification study)
Time frame: Up to 13 years
Fatigue (Intensification study)
Time frame: Up to 13 years
Secondary Endpoints
MFS
Overall survival
Prostate cancer specific mortality (PCSM)
Eligibility Criteria
Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION * Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration * High-risk disease defined as having at least one or more of the following: * PSA \> 20 ng/mL prior to starting ADT * Note: Patients receiving a 5-alpha reductase inhibitor (ex. finasteride) at the time of enrollment are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors and the medication should be discontinued prior to randomization but a washout period is not required * cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer \[AJCC\] 8th edition \[Ed.\]) * Gleason score of 8-10 * Node positive by conventional imaging with a short axis of at least 1.0 cm * Appropriate stage for study entry based on the following diagnostic workup: * History/physical examination within 120 days prior to registration; * Bone imaging within 120 days prior to …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →