NCT05038332RecruitingPhase 2
Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 31 Aug 2021
- Start date
- 12 Nov 2021
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT05038332
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 136
- From 12 Nov 2021 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of pelvic radiation therapy
- Initiation of androgen deprivation therapy with a LHRH / GnRH agonist or antagonist greater than 6 months prior to enrollment or receipt of any non-LHRH / GnRH agonist or antagonist androgen deprivation or anti-androgen therapy
Other illness
- History of moderate/severe or active Crohn's disease or ulcerative colitis
- History of bladder neck or urethral stricture
- Evidence of distant metastatic disease or nodal involvement beyond the common iliac vessels
- History of another invasive malignancy within the previous 3 years except for adequately treated squamous or basal cell skin cancer
- Any condition that in the opinion of the investigator would preclude participation in this study
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Rogel Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.