RecruitingInterventionalPhase 2

A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy

NCT ID: NCT05038332Sponsor: University of Michigan Rogel Cancer CenterLast updated: 2026-01-16

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).

Detailed description

Conventional or moderately hypo-fractionated radiation therapy are the current standard of care treatment options for men receiving post-prostatectomy radiation therapy. These treatment regimens typically span 4-8 weeks, representing a high burden of therapy, which may result in decreased utilization of salvage radiotherapy, the only potentially curable treatment for men with relapsed disease following prostatectomy. Ultra-hypofractionated radiation therapy (also known as stereotactic body radiation therapy \[SBRT\]) would decrease the total number of treatments to 5, delivered over 2 weeks, which would greatly reduce treatment burden.

Arms & interventions

RadiationUltra-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)
RadiationModerately 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)

Outcome measures

Primary

Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
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.
Time frame: 2-years post-treatment

Secondary

Patient reported GU quality of life (QOL) up to 60 months
Time frame: 60 months post-treatment
Patient reported GI quality of life (QOL) up to 60 months
Time frame: 60 months post-treatment
Treatment related toxicity - acute
Time frame: ≤ 90 days after treatment completion
Treatment related toxicity - late
Time frame: >90 days after treatment completion, up to 5 years
Time to progression
Time frame: up to 5 years
Rate of biochemical failure
Time frame: up to 5 years
Local failure, Regional failure, Distant metastases
Time frame: up to 5 years
Prostate cancer specific survival
Time frame: up to 5 years
Overall survival
Time frame: up to 5 years

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 98107

Recruiting

William Jackson, MD · Principal Investigator