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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT05038332
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultra-hypofractionated radiation therapy — RADIATION
    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 — RADIATION
    55 Gy in 20 fractions to prostate bed, daily, M-F, 4 weeks (42 Gy in 20 fractions to pelvic lymph nodes if included)

Study Details

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 Dates

Start date
Nov 12, 2021
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2029

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan98107
William Jackson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MI

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