NRG-GU010

Open to Accrual

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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

Co-Principal Investigator(s)

Alejandro Berlin

Status

Open to Accrual

Date Opened To Accrual

November 3, 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 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.

Patient Population

2050

Target Accrual

2050

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.

Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.

Protocol Information