Recruiting
Phase 2

Moderate & Ultra-hypofractionated

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT05038332

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultra-hypofractionated radiation therapy

Moderately Hypo-fractionated Radiation Therapy

Study Details

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).

Conditions

Prostate Cancer

Study ID

NCT05038332

Start date

Nov 12, 2021

Status verified date

Jan, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Moderately Hypo-fractionated Radiation Therapy

20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.

experimental: Ultra-Hypofractionated Radiation Therapy

5 fractions of ultra-hypofractionated radiation therapy with at least one day between each treatment over the course of no more than 3-4 weeks

Interventions

Ultra-hypofractionated radiation therapy

34 Gy in 5 fractions to prostate bed, every other day, M-F, \~2 weeks (25 Gy in 5 fractions to pelvic lymph nodes if included)

Moderately Hypo-fractionated Radiation Therapy

55 Gy in 20 fractions to prostate bed, daily, M-F, 4 weeks (42 Gy in 20 fractions to pelvic lymph nodes if included)

Primary outcome measure

  • Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline [ Time Frame: 2-years post-treatment ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

1-800-865-1125CancerAnswerLine@med.umich.edu

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 98107

Principal Investigator:

William Jackson, MD

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Stereotactic Body Radiation Therapy (SBRT)
  • Ultra-hypofractionated Radiation Therapy
  • Post-prostatectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-01-16.