Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-21-217
Prinicipal Investigator
Miccio, Joseph
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
NRG-GU010
Title
Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)
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 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.
Applicable Disease Sites
Prostate
Status
Open
Participating Institutions
Hershey Medical Center