Several NRG Oncology Prostate Cancer Trials Reached Their Accrual Goals

09/16/2026

NRG Oncology is incredibly proud that 4 prostate cancer studies met their accrual goals within the last year! These trials aim to shift the way the oncology community approaches prostate cancer treatment. We look forward to the reported results of these trials as they become available. Congratulations to our study chairs, sites, research staff, and especially our patients and their families for enrolling on these important studies.

NRG-GU008: Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE*) *INtensifying treatment for NOde positive prostate cancer by VArying the hormonal ThErapy

The INNOVATE (NRG-GU008) trial is examining whether the addition of the hormone therapy drug apalutamide to the current standard of care improves metastasis-free survival (MFS) in patients with node-positive prostate cancer who have detectable prostate-specific antigens (PSAs) following a radical prostatectomy. Patients on the study receive either salvage radiotherapy and a GnRH agonist/antagonist (the current standard of care) or to receive radiotherapy and a GnRH agonist/antagonist plus apalutamide (a more aggressive treatment).

“Node-positive prostate cancer is a potentially curable form of Stage 4 prostate cancer but patient outcomes are suboptimal because very few clinical trials have focused on this patient population. NRG-GU008 is significant because it is the largest trial to date dedicated to improving the cure rates for patients with node-positive prostate cancer.”

-Ronald Chen, MD, Principal Investigator of the NRG-GU008 trial.

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*)

The NRG-GU009 “PREDICT-RT” study is evaluating intensified and de-intensified concurrent radiation regimens based on the genomic risk of patients with high-risk prostate cancer. The PREDICT-RT study stratifies enrolled patients with high-risk cancer by Decipher Risk Score. The Decipher Risk Score determined whether each patient should be assigned to the de-intensification cohort or the intensification cohort. The primary objective of the De-intensification study is to determine whether men with high-risk prostate cancer in a lower Decipher score range can be treated with less ADT and achieve metastasis-free survival results not worse than standard ADT. The primary objective of the Intensification study is to determine whether the addition of apalutamide to the standard of care can help improve metastasis-free survival for men with high-risk prostate cancer in a higher Decipher score range.

“The incidence of men receiving high-risk prostate cancer diagnoses is on the increase in recent years. The PREDICT-RT 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 scores, which uses the tumor’s genetic information to predict aggressiveness”

-Paul Nguyen, MD, Principal Investigator of the PREDICT-RT trial.

NRG-GU010: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)

The GUIDANCE (NRG-GU010) trial is examining, in patients with unfavorable intermediate risk prostate cancer, both whether patients with a lower Decipher genomic risk score could be treated as effectively with a less intensive treatment than the current standard of care and whether patients with a higher Decipher genomic risk score would have improved metastasis-free survival with a more intensive treatment than the current standard of care. Patients’ tumors  will undergo the Decipher genomic risk test and then be stratified based on whether they have high or low genomic risk. Patients with low genomic risk will be randomized to receive either the standard of care (radiotherapy plus six months of ADT) or radiotherapy alone. Patients with high genomic risk will be randomized to receive either the standard of care or the standard of care plus 6 months of the hormone therapy drug darolutamide.

“The completion of NRG-GU010 accrual ahead of schedule — exceeding 2,000 patients in approximately four years — reflects the importance the genitourinary oncology community continues to place on practical, cooperative group-led efforts addressing patient-centered questions in treatment personalization.

This study leverages genomic risk stratification (Decipher) to address the recognized heterogeneity within unfavorable intermediate-risk prostate cancer, helping determine not only the appropriate intensity of androgen deprivation therapy, but whether it is needed at all. At the same time, the trial evaluates the potential benefit of treatment intensification with darolutamide in genomically higher-risk subgroups. The overarching goal is clear: preserve quality of life where escalation is unnecessary while maximizing benefit where additional therapy may matter most.

A permissive radiotherapy approach, combined with integration of modern treatment techniques and robust NRG radiation therapy quality assurance, facilitated broad participation across diverse practice settings and geographic regions. The commitment of patients, investigators, research teams, and the broader NRG network positions this study to generate practice-changing evidence for one of the most common and often challenging treatment decisions in curative-intent prostate cancer care.”

-Neil Desai, MD, and Alejandro Berlin, MD, Principal Investigators of the NRG-GU010 trial.

NRG-GU011: A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy with or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

The PROMETHEAN (NRG-GU011) trial is examining whether the addition of hormone therapy to radiotherapy will reduce the development of new metastases in patients who have previously been treated for prostate cancer with either surgery or radiation and now have oligometastatic disease as detected by a PET scan. Patients on the study are randomized to receive either radiotherapy alone (a standard therapy) with a placebo or radiotherapy plus androgen deprivation therapy (ADP) in the form of the hormone therapy drug relugolix.

“The study team and I are excited that we completed accrual to NRG-GU011 earlier this year. This study is important because it tests the interaction between short course testosterone suppression and metastasis directed ablative radiotherapy (MDT). A few studies have come out since this study was designed, but our design will add to these because it specifically evaluates both cancer outcomes (radiographic progression-free survival is the primary endpoint) and quality of life outcomes so it will educate us as radiation oncologists so we can better educate our patients as to the pros and cons of MDT with or without hormonal therapy.”

-Bridget Koontz, MD, Principal Investigator of the NRG-GU011 trial.