The Phase III 'High Five Trial' Five Fraction Radiation For High-Risk Prostate Cancer
Categories (click each to see list of all clinical trials associated with that category): GU (ONC), Radiation Oncology (RADONC)
Current Status: Open
Phase: III
Principal Investigator: Baine, Michael
Contact Information:
Micki Bethea, BS
+1 402-559-8011
mbethea@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05946213?term=NCT05946213&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation.
SECONDARY OBJECTIVES:
I. To compare physician-reported toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 between treatment arms.
II. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by Expanded Prostate Cancer Index Composite [EPIC]-26 urinary domains).
III. 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).
IV. To compare patient-reported fatigue (assessed by Patient Reported Outcomes Measurement Information System [PROMIS]-Fatigue) between treatment arms.
V. To compare failure-free survival between treatment arms.
VI. To compare metastasis-free survival based on molecular imaging between treatment arms.
VII. To compare overall survival between treatment arms.
EXPLORATORY OBJECTIVES:
I. To compare patient-reported sexual function (assessed by EPIC-26 sexual domain) between treatment arms.
II. To compare patient-reported quality of life (assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between treatment arms.
III. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity (COST) between treatment arms.