Study Comparing Two Types of Radiation Therapy After Prostate Surgery: Moderate vs. Ultra-hypofractionated (SBRT)
Sponsor: University of Michigan Rogel Cancer Center
ClinicalTrials ID:NCT05038332
This clinical trial is comparing the quality of life in prostate cancer patients two years after receiving two different types of radiation therapy following prostate surgery. The study aims to see if a shorter, more intense treatment (SBRT) affects patients' quality of life differently than the current standard treatment.
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Program Overview
The main goal of this study is to compare how prostate cancer patients feel about their quality of life two years after receiving one of two types of radiation therapy following prostate surgery. One type is the standard treatment, which takes 4-8 weeks, and the other is a shorter, more intense treatment called ultra-hypofractionated radiation therapy or SBRT, which takes only 2 weeks. Researchers want to see if the shorter treatment is just as effective and how it impacts patients' lives.
Description
Currently, men who need radiation therapy after prostate surgery usually undergo treatments that last 4-8 weeks. This can be a long and demanding process, which might discourage some men from completing the treatment. The study is testing a new approach called ultra-hypofractionated radiation therapy, also known as SBRT, which reduces the number of treatments to just 5 sessions over 2 weeks. This could make the treatment process easier and less burdensome for patients. The study will compare the quality of life of patients who receive the standard treatment with those who receive the shorter SBRT treatment to see if there are any differences.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older who have been diagnosed with prostate cancer and have had prostate surgery, with a PSA level of 0.1 ng/mL or higher.
- At least 6 months must have passed since the prostate surgery before starting radiation therapy.
- Must have a Karnofsky Performance Status (KPS) score of 70 or higher, indicating they are able to care for themselves.
- Patients with uncertain pelvic lymph node involvement on imaging are eligible if the nodes are 1.5 cm or smaller.
- Must be able to complete a quality of life questionnaire called EPIC-26.
- Must be able to provide tissue samples from the prostate surgery for review.
- Must understand and agree to sign a written consent form to participate in the study.
Exclusion Criteria
- Have had previous radiation therapy to the pelvic area.
- Have a history of moderate to severe Crohn's disease or ulcerative colitis.
- Have a history of bladder neck or urethral stricture.
- Have evidence of cancer spread beyond the common iliac vessels.
- Have started hormone therapy more than 6 months before joining the study or have received certain types of hormone therapy.
- Have had another invasive cancer within the last 3 years, except for certain skin cancers.
- Have any condition that the study doctor believes would make it unsafe to participate in the study.
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