Parallel Phase III Randomized Trials Of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (Guidance)
Principal Investigator
Neil DeSai, MD, MHS
Co-Principal Investigator(s)
Alejandro Berlin, MD, MSc
Status
Open to Accrual
Date Opened To Accrual
November 03 2021
Disease Site
Genitourinary [GU]
Prostate
Phase
III
Developmental Therapeutics
Yes
Primary Objective
De-Intensification Study: To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with RT alone instead of 6 months ADT + RT experience non-inferior rate of distant metastasis.
Intensification Study: To determine whether men with NCCN UIRprostate cancer who are in the higher genomic risk (Decipher score ≥0.40) willhave a superior metastasis-free survival through treatment intensification withdarolutamide added to the standard of RT plus 6 months ADT.
Patient Population
2050
Target Accrual
2050