This phase II trial compares the effect of moderate-hypofractionated radiation therapy to ultra-hypofractionated radiation therapy in treating patients with prostate cancer after surgery (post-prostatectomy). Moderate-hypofractionated radiation therapy is the current standard of care treatment option post-prostatectomy. It is typically given over 4-8 weeks, representing a high burden of therapy, which may result in decreased use of salvage radiation therapy, the only potentially curable treatment for prostate cancer that has come back after prostatectomy. Ultra-hypofractionated radiation therapy would decrease the total number of treatments to 5, delivered over 2 weeks, which would greatly reduce treatment burden. The purpose of this study is to compare moderate-hypofractionated radiation therapy to ultra-hypofractionated radiation therapy, and may demonstrate that ultra-hypofractionated radiation therapy does not significantly worsen subject reported outcomes at 2 years after treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05038332.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Rogel Cancer CenterStatus: Active
Contact: William C Jackson
Phone: 734-647-9956
PRIMARY OBJECTIVE:
I. To determine whether ultra-hypofractionated radiation therapy is non-inferior to moderately hypofractionated radiation therapy with regards to 2-year post-treatment patient reported genitourinary (GU) and gastrointestinal (GI) quality of life in men receiving post-prostatectomy radiation therapy.
SECONDARY OBJECTIVES:
I. To compare patient reported GU quality of life at end of treatment, and at 3, 6, 12, 24, and 60 months post-treatment between treatment arms.
II. To compare patient reported GI quality of life at end of treatment, and at 3, 6, 12, 24, and 60 months post-treatment between treatment arms.
III. To compare GU/GI treatment toxicity between treatment arms, (regardless of attribution), at ≤ 90 days after treatment completion and > 90 days after treatment completion.
IV. To compare time to progression (where progression is defined as the first occurrence of biochemical failure, local failure, regional failure, distant metastasis, start of salvage therapy, or death from prostate cancer) between treatment arms.
V. To compare rates of biochemical failure, local failure, regional failure, distant metastasis, start of salvage therapy, death from prostate cancer, and overall survival between treatment arms.
EXPLORATORY OBJECTIVES:
I. Whole blood will be collected for translational research analyses for predictors of cancer control and toxicity following moderately hypofractionated or ultra-hypofractionated post-prostatectomy radiotherapy.
II. To compare utilities for health outcomes using the European Quality of Life Five Dimension (EQ-5D).
III. To compare patient financial toxicity between treatment arms using the Comprehensive Score for financial Toxicity (COST) measure.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo moderate-hypofractionated radiation therapy once daily (QD) Monday-Friday for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the trial.
ARM II: Patients undergo ultra-hypofractionated radiation therapy at least every other day Monday-Friday for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at 3 and 6 months, every 6 months for years 1-2, and then annually for years 3-5.
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorWilliam C Jackson
