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

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Hypo-fractionated Radiation Therapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
University of Michigan Rogel Cancer Center
RECRUITING
Ann Arbor
Contact Information
Primary
Cancer AnswerLine
CancerAnswerLine@med.umich.edu
1-800-865-1125
Time Frame
Start Date: 2021-11-12
Estimated Completion Date: 2029-11
Participants
Target number of participants: 136
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of Michigan Rogel Cancer Center

This content was sourced from clinicaltrials.gov