Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
Parallel Phase III Randomized Trials of Genomic Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)
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.
Study Documents
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