The “High Five Trial” for High-Risk Prostate Cancer Activates (NRG-GU013)

December 11 2023

NRG-GU013 (High Five Trial): The Phase III ‘High Five Trial’ Five Fraction Radiation for High-Risk Prostate Cancer

The NRG-GU013, also known as the “High Five Trial” activated to high-risk prostate cancer patient enrollment in November 2023. Trial participants will be stratified by pelvic lymph node treatment, length of androgen deprivation therapy (ADT), treatment with second generation anti-androgen and treatment with a microboost. After stratification, patients will be randomly assigned to either Group 1 where they will receive stereotactic body radiation therapy (SBRT) in 5 fractions or Group 2 where they will receive radiation in conventional or moderate hypofractionation in 20-45 fractions. The primary objective of the High Five Trial is to determine if SBRT does not have worse metastasis-free survival for this patient population when compared to the conventional or moderate hypofractionation regimen.

“Prior studies have indicated that a five-treatment regimen to the prostate can be delivered safely and effectively to men with low and intermediate-risk prostate cancer, but randomized data is lacking for patients with high-risk prostate cancer treated with radiation and ADT.” stated NRG-GU013 Principal Investigator (PI), Karen Hoffman, MD MPH MHSc FASTRO, of the MD Anderson Cancer Center at the University of Texas. “The High-Five Trial seeks to establish 5-fraction SBRT as a standard of care for high-risk prostate cancer by demonstrating non-inferior metastasis-free survival compared to more protracted regimens.”

“There is no surprise that delivering radiation over a shorter period of time, when safe and effective, creates less of a burden for patients as they undergo their cancer treatment. If this shortened regimen demonstrates non-interior cancer outcomes and similar toxicity, it will become an efficient standard for treating this high-risk population,” added NRG-GU013 Co-PI, Paul Nguyen, MD MBA FASTRO, of the Dana-Farber Cancer Institute and Brigham and Women’s Hospital.

In addition to metastasis-free survival, the High Five Trial will compare physician-reported toxicity, patient-reported fatigue, patient-reported treatment burden, failure-free survival, metastasis-free survival based on molecular imaging, and overall survival between treatment arms. This study is also designed to determine if SBRT is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary and bowel function. Exploratory objectives include the comparison of patient-reported sexual function and quality of life between treatment arms.

Protocol documents and materials are located on the CTSU website

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