Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
NCT05038332 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2026-01-16
Summary
The primary purpose of this study is to compare the quality of life (QOL) reported by prostate cancer patients 2 years after treatment with ultra-hypofractionated post-prostatectomy radiation therapy (also known as stereotactic body radiation therapy \[SBRT\]) versus the self-reported QOL of those treated with moderately hypo-fractionated post-prostatectomy radiation (a current standard of care option).
Conditions
Interventions
- RADIATION
-
Ultra-hypofractionated radiation therapy
34 Gy in 5 fractions to prostate bed, every other day, M-F, \~2 weeks (25 Gy in 5 fractions to pelvic lymph nodes if included)
- RADIATION
-
Moderately Hypo-fractionated Radiation Therapy
55 Gy in 20 fractions to prostate bed, daily, M-F, 4 weeks (42 Gy in 20 fractions to pelvic lymph nodes if included)
Sponsors & Collaborators
-
University of Michigan Rogel Cancer Center
lead OTHER
Principal Investigators
-
William Jackson, M.D. · University of Michigan Rogel Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-12
- Primary Completion
- 2026-11-30
- Completion
- 2029-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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