Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known a
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 moderate
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | Inclusion Criteria: * Men age ≥ 18 with histologically confirmed prostate cancer after radical prostatectomy with a PSA ≥ 0.1 ng/mL * Interval between prostatectomy and planned radiation therapy start date ≥ 6 months * KPS ≥ 70 * Patients with equivocal pelvic lymph nodes on imaging are eligible if the nodes are ≤ 1.5 cm in the short axis (equivocal evidence of metastatic disease outside of the pelvis on standard imaging requires documented negative biopsy) * Ability to complete the EPIC-26 quality of life questionnaire * Ability to obtain tissue from radical prostatectomy specimen for review by Michigan Medicine Pathology * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Prior history of pelvic radiation therapy * History of moderate/sev |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | University of Michigan Rogel Cancer Center |
| Locations | Ann Arbor, Michigan, United States |
| Start date | 2021-11-12 |
| NCT ID | NCT05038332 |
| Official listing | https://clinicaltrials.gov/study/NCT05038332 |