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*)
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Baine, Michael
Contact Information:
Heather Mittelstedt
hmittelstedt@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04513717?term=NCT04513717&rank=1
Summary
1.1.1 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.
1.1.2 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 added to the standard of RT plus 24 month ADT.
1.2 Secondary Objectives for both De-Intensification and Intensification Studies
1.2.1 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).
1.2.2 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).
1.2.3 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).
1.2.4 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).
1.2.5 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).
1.2.6 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).
1.2.7 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).
1.2.8 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).
1.3 Exploratory Objectives for both De-Intensification and Intensification Studies
1.3.1 To compare changes in cardio-metabolic markers, including body mass index, and waist circumference, 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).
1.3.2 To develop a machine learning/artificial intelligence algorithm for radiotherapy quality assurance.
1.3.3 To perform future translational correlative studies using biological and imaging data.
1.3.4 Impact of PET use, measured by the proportion of times each type of imaging was used, in high-risk prostate cancer
1.4 Patient-Reported Outcomes Objectives for De-Intensification Study
1.4.1 Primary Objective
To compare sexual and hormonal function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT).
1.4.2 Secondary Objective
1.5 - see protocol