NRG-GU013: The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer
Objective
Primary Objective: To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (SBRT) to those randomized to moderate hypofractionation and conventional fractionation.
Secondary Objective: To compare physician-reported toxicity as measured by CTCAE v5 between treatment arms. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by EPIC-26 urinary domains). To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain). To compare patient-reported fatigue (assessed by PROMIS-Fatigue) between treatment arms. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity (COST)) between treatment arms. To compare failure-free survival between treatment arms. To compare metastasis-free survival based on molecular imaging between treatment arms. To compare overall survival between treatment arms.
