NCT05038332 Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
| NCT ID | NCT05038332 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Michigan Rogel Cancer Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2021-11-12 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 136 participants in total. It began in 2021-11-12 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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/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 * 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 * 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
Contact & Investigator
William Jackson, M.D.
PRINCIPAL INVESTIGATOR
University of Michigan Rogel Cancer Center
Frequently Asked Questions
Who can join the NCT05038332 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05038332 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05038332 currently recruiting?
Yes, NCT05038332 is actively recruiting participants. Contact the research team at CancerAnswerLine@med.umich.edu for enrollment information.
Where is the NCT05038332 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05038332 clinical trial?
NCT05038332 is sponsored by University of Michigan Rogel Cancer Center. The principal investigator is William Jackson, M.D. at University of Michigan Rogel Cancer Center. The trial plans to enroll 136 participants.
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