Sponsor: NRG
Sponsor Study ID: GU010
Study Title: Parallel Phase III Randomized Trials of Genomic Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)
CTO #: 103596
NCT Number: NCT05050084
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Prostate
Study Objectives: 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. To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk (Decipher score ≥0.40) will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT.