NRG-GU009 ( “PREDICT-RT”) 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

September 15 2022

Written by Oliver Sartor, MD, Tulane Medical School

Prostate cancer patients with high-risk non-metastatic disease are typically treated with surgery or external beam radiation therapy (EBRT) + 2 years of androgen deprivation therapy. In the NRG 009 (PREDICT-RT) trial, these men are segregated with a genomics classifier (DECIPHER) into those with higher- or lower-risk disease. 

In this randomized trial, men with higher risk on DECIPHER (or pelvic node positive disease) are treated with EBRT + two years of androgen deprivation therapy (ADT) or the same treatment plus apalutamide. Apalutamide is an androgen receptor antagonist which has been shown to prolong survival in men with more advanced disease. For the high-risk men there is a superiority end point with the primary endpoint being metastasis-free survival (MFS). 

Men with lower-risk disease according to the genomic classifier men are treated with EBRT + two years of ADT in the control arm as compared to EBRT + one year of ADT to de-intensify therapy. The primary endpoint is MFS assessed in a non-inferiority design. A variety of secondary endpoints will assess the effects of de-intensified therapy on patient reported outcomes (and more).  

The goals of the trial are simple. Men at the highest risk of relapse will be randomized to intensification of therapy to ascertain whether or not such intensification can be associated with improvements in MFS (which is strongly correlated with overall survival in prior studies). Men with lower risk disease will have therapeutic de-intensification to ascertain if men can have less intense therapy and still have similar MFS outcomes. Such de-intensification may be associated with less side effects and better quality of life. 

This is the first large prospective randomized trial in prostate cancer to include a genomic classifier to personalize therapy.  

See the NRG website protocol table section here for more information on the trial.

Be sure to share the NRG study patient webpage located here.

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