December 09 2021
NRG-GU008: Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging into Treatment for Patients with Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE)
NRG-GU008, the INNOVATE trial, reopened to patient accrual on December 01, 2021, following the removal of abiraterone acetate with prednisone from the protocol treatment for all newly accrued trial participants. The experimental arm of NRG-GU008 was modified to a single agent treatment due to the results of the ACIS trial (NCT02257736) that were presented at the American Society of Clinical Oncology Genitourinary Cancers (ASCO GU) 2021 Meeting that demonstrated the combination of abiraterone acetate with prednisone and apalutamide increased toxicity and did not improve overall survival for patients.
The trial will continue to accrue patients who have undergone a radical prostatectomy and were found to have node-positive disease on surgical pathology with detectable PSA. Trial participants will be randomly assigned to receive either radiotherapy and a gonadotropin-releasing hormone (RT+ GnRH) agonist for 2 years (Treatment Arm 1), or RT+ GnRH with the addition of apalutamide for 2 years (Treatment Arm 2).
NRG-GU008 will primarily aim to determine if the addition of apalutamide improves metastasis-free survival for patients with node-positive prostate cancer. Additionally, the trial will 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.
For patients who were enrolled prior to amendment 2 and who choose to continue abiraterone acetate with prednisone, associated assessments, treatment, dose modification, adverse event reporting, and drug information have been retained with the qualifying statement that the protocol directives related to abiraterone acetate with prednisone only refer to those patients enrolled prior to amendment 2 who are continuing to receive abiraterone acetate with prednisone.
“Node-positive prostate cancer is an extremely aggressive disease that has been unfortunately understudied in a clinical trial setting. It is important to establish an optimal treatment option and improve outcomes for this patient population,” stated Ronald Chen, MD, MPH, of the University of Kansas Medical Center and the Principal Investigator of the NRG-GU008 study.
Learn more about this trial on ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website.