NRG-GU009

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation (PREDICT-RT*)

Principal Investigator

Paul L. Nguyen, MD

Co-Principal Investigator(s)

A. Oliver Sartor, MD

Status

Disease Site

Genitourinary [GU] Prostate

Phase

III

Developmental Therapeutics

Yes

Primary Objective

De-Intensification Study: To determine whether men with NCCN high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk ( < 0.85) can be treated with 12 months ADT plus RT instead of 24 months ADT+RT and experience non-inferior metastasis-free survival.

Intensification Study: To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk ( > 0.85) or have node-positive disease by conventional imaging (MRI or CT scan) will have a superior metastasis-free survival (MFS) through treatment intensification with apalutamide added to the standard of RT plus 24 month ADT.

NRG-GU008 / NRG-GU009 Study Update Webinar

 

Watch Recording

 

Patient Population

Pathologically proven diagnosis of adenocarcinoma of prostate cancer and are high-risk disease.

Target Accrual

2478