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Post-Prostatectomy Radiation Therapy for Prostate Cancer

This study is comparing two types of radiation therapy after prostate surgery for prostate cancer: ultra-hypofractionated radiation therapy (also known as SBRT) and moderately hypofractionated radiation therapy. Ultra-hypofractionated radiation therapy is given in 5 treatments over about 2 weeks, while moderately hypofractionated radiation therapy is given in 20 treatments over 4 weeks. The main goal is to see how these treatments affect your quality of life related to your bowel and urinary function two years after treatment. You may be able to join if you are a man aged 18 or older with prostate cancer, have had a prostatectomy, and your PSA is 0.1 ng/mL or higher. The current recruitment status is unclear.

Study design
This study plans to enroll 136 men and compares two different radiation therapy schedules. It is an interventional study, meaning participants will receive one of the study treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be assessed two years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05038332

Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Michigan Rogel Cancer Center
~136 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:Ultra-hypofractionated radiation therapyModerately Hypo-fractionated Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
Measured over 2-years post-treatment

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • William Jackson, M.D. · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Cancer AnswerLine
[email protected]
1-800-865-1125
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline2-years post-treatment

    GI and GU QOL assessed with the EPIC-26 questionnaire, bowel and urinary domains. Change scores will be calculated as baseline score subtracted from 2-year score. All patients with EPIC bowel and urinary domain scores will be included in the primary endpoint analysis. The EPIC scoring manual will be followed which requires ≥ 80% of items in a domain to be completed in order to obtain a score for that domain. High bowel score \>96, low bowel score \<= 96, high urinary score \> 84, low urinary score \<=84.