The target enrollment has been met in the phase 3 PREDICT-RT (NRG-GU009; NCT04513717) trial, evaluating a risk stratification method for assigning patients with high-risk prostate cancer to either de-intensified or intensified concurrent hormone therapy and radiation regimens, NRG Oncology announced in a news release.1
In total, the study enrolled 2478 adult patients across clinical trial sites in the US and Canada.2 Patients in the study will undergo Decipher genomic testing, which will be used to determine whether they should be assigned to receive de-intensified treatment or intensified treatment.
“The incidence of men receiving high-risk prostate cancer diagnoses is on the increase in recent years,” explained principal investigator Paul L. Nguyen, MD, MBA, of the Mass General Brigham and Dana Farber Cancer Centers, Boston, Massachusetts, in the news release.1 “The PREDICT-RT study was designed to improve quality of life and outcomes for these patients while tailoring treatments to meet each individual’s needs based on their Decipher Prostate Genomic Classifier scores, which use the tumor’s genomic information to predict aggressiveness.”
For the study, patients with a low Decipher risk score (less than or equal to 0.85) will be assigned to the de-intensification study, and those with a high Decipher risk score (greater than 0.85 or node positive disease) will be assigned to the intensification study.
In the de-intensification study, participants will be randomly assigned to receive either standard of care radiotherapy and 24 months of androgen deprivation therapy (ADT) (arm 1) or to radiotherapy and 12 months of ADT (arm 2). Patients in this study were stratified by Decipher score range, boost type, prior pelvic treatment, and ACE-27 comorbidity.
In the intensification study, patients will be randomly assigned to receive standard of care radiotherapy with 24 months of ADT (arm 3) or to radiotherapy with 24 months of ADT plus 24 months of apalutamide (Erleada) (arm 4). Patients in this study were stratified by boost type, prior pelvic treatment, and nodal status.
The primary end point for the studies is metastasis-free survival (MFS).
Specifically, the de-intensification study is seeking to determine whether patients with high-risk prostate cancer and a low Decipher score can achieve non-inferior MFS with a de-intensified treatment regimen compared with standard ADT. In the intensification study, the primary objective is to determine whether adding apalutamide to the standard of care regimen can improve MFS in patients with high-risk prostate cancer and a high Decipher score.
The other co-primary end points for the study encompass patient-reported quality of life measures. Secondary objectives include overall survival, prostate cancer-specific survival, prostate-specific antigen failure-free survival, time to testosterone recovery, and safety.
Patients in the study will be followed for up to 13 years. Final completion of the trial is expected in December 2033.
“Our study team would like to thank our sites and our patients who quickly enrolled to this very important trial,” concluded co-principal investigator Oliver Sartor, MD, of East Jefferson General Hospital Cancer Center, Metairie, Louisiana, in the news release.1 “We look forward to reporting the results as data becomes available from this trial.”
REFERENCES
1. NRG Oncology PREDICT-RT study completes patient accrual, tests individualized concurrent therapy and radiation for high-risk prostate cancer. News release. NRG Oncology. September 18, 2025. Accessed September 26, 2025. https://www.eurekalert.org/news-releases/1098858
2. Two studies for patients with high risk prostate cancer testing less intense treatment for patients with a low gene risk score and testing a more intense treatment for patients with a high gene risk score, the PREDICT-RT trial. ClinicalTrials.gov. Last updated September 11, 2025. Accessed September 26, 2025. https://clinicaltrials.gov/study/NCT04513717