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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer

In brief

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).

Key facts

Study ID

NCT05038332

Run by

University of Michigan Rogel Cancer Center

People needed

136

Starts

2021-11-12

Expected to finish

2029-11-01

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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