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*) *Prostate RNA Expression/Decipher To Individualize Concurrent Therapy with Radiation

Principal Investigator

Paul L. Nguyen, MD,

Co-Principal Investigator(s)

A. Oliver Sartor, MD

Status

Open to Accrual

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 ofprostate cancer and are high-risk disease. 

Target Accrual

2478