NRG Oncology Trial Explores the Addition of Novel Hormonal Therapy Agents to the Usual Treatment for Node-Positive Prostate Cancer

April 15 2020

NRG Oncology Trial Explores the Addition of Novel Hormonal Therapy Agents to the Usual Treatment for Node-Positive Prostate Cancer

NRG-GU008: Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer after Radical Prostatectomy opened to enrollment on March 5, 2020.

Node positive prostate cancer is a very aggressive but potentially curable disease; however, very few clinical trials have examined the optimal treatment for this patient population. NRG-GU008 is for patients who have undergone a radical prostatectomy and were found to have node-positive disease on surgical pathology; patients must also have a detectable PSA to be eligible. This trial will compare the addition of abiraterone acetate, prednisone, and apalutamide to salvage radiotherapy combined with a gonadotropin-releasing hormone (RT+ GnRH) agonist with the RT + GnRH regimen alone to determine if either treatment improves metastasis-free survival (MFS). Participants on this trial will be stratified by their PSA history following prostatectomy prior to being randomly assigned to one of the two treatment arms.

NRG-GU008 will also compare health-related quality of life, overall survival, biochemical progression-free survival, time to local-regional progression, time to castrate resistance, and cancer-specific survival, and short-term and long-term treatment-related adverse events between the treatment arms. There are also exploratory objectives on this trial utilizing biomarkers.

“Node-positive prostate cancer is classified as ‘Stage 4’ disease and has been understudied in clinical trials. This trial is the only one specifically for node-positive patients and will determine if adding novel hormonal agents to standard treatment will improve the outcomes for these patients,” stated Ronald Chen, MD, MPH, of the University of Kansas Medical Center and Principal Investigator of the NRG-GU008 trial.

Learn more about this trial on ClinicalTrials.gov

Access the protocol documents and materials on CTSU.org


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