← Back to Search

Radiation Therapy

Moderate vs Ultra-Hypofractionated Radiation for Prostate Cancer

Phase 2
Recruiting
Led By William Jackson, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to obtain tissue from radical prostatectomy specimen for review by Michigan Medicine Pathology
Interval between prostatectomy and planned radiation therapy start date ≥ 6 months
Must not have
History of moderate/severe or active Crohn's disease or ulcerative colitis
History of bladder neck or urethral stricture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will compare the quality of life of prostate cancer patients treated with two different types of radiation therapy.

Who is the study for?
Men aged 18+ who've had prostate cancer confirmed by tissue review after surgery, with a PSA level of at least 0.1 ng/mL. They should be able to start radiation therapy at least 6 months post-surgery and have a KPS score of 70 or above, indicating they can carry out daily activities. Participants must be capable of completing a quality-of-life survey and provide consent.Check my eligibility
What is being tested?
This study compares two types of radiation therapy for prostate cancer patients after surgery: ultra-hypofractionated (SBRT) versus moderately hypo-fractionated radiation. The main goal is to see which treatment leads to better self-reported quality of life two years later.See study design
What are the potential side effects?
Radiation therapy side effects may include skin changes, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding, and potential sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can provide tissue from my prostate surgery for review.
Select...
It has been 6 months or more since my prostate surgery.
Select...
I am a man over 18 with prostate cancer confirmed by biopsy after surgery, and my PSA level is at least 0.1 ng/mL.
Select...
I am mostly able to care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of moderate to severe Crohn's disease or ulcerative colitis.
Select...
I have had a narrowing of my bladder neck or urethra.
Select...
My cancer has spread to distant areas or to nodes beyond my pelvis.
Select...
I haven't had any cancer except for skin cancer in the last 3 years.
Select...
I have had radiation therapy in the pelvic area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
Secondary outcome measures
Local failure, Regional failure, Distant metastases
Overall survival
Patient reported GI quality of life (QOL) up to 60 months
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ultra-Hypofractionated Radiation TherapyExperimental Treatment1 Intervention
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
Group II: Moderately Hypo-fractionated Radiation TherapyActive Control1 Intervention
20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments primarily include androgen deprivation therapy (ADT) and radiation therapy. ADT works by lowering testosterone levels, which prostate cancer cells rely on for growth, thereby slowing disease progression. Stereotactic Body Radiation Therapy (SBRT) delivers high doses of radiation in a few sessions, precisely targeting cancer cells while sparing surrounding healthy tissue. This precision reduces side effects and improves the quality of life for patients. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, balancing efficacy and potential side effects.
Stereotactic body radiation therapy for prostate cancer: systematic review and meta-analysis of prospective trials.

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
295 Previous Clinical Trials
24,154 Total Patients Enrolled
28 Trials studying Prostate Cancer
2,850 Patients Enrolled for Prostate Cancer
William Jackson, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Prostate Cancer
100 Patients Enrolled for Prostate Cancer

Media Library

Moderately Hypo-fractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05038332 — Phase 2
Prostate Cancer Research Study Groups: Moderately Hypo-fractionated Radiation Therapy, Ultra-Hypofractionated Radiation Therapy
Prostate Cancer Clinical Trial 2023: Moderately Hypo-fractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT05038332 — Phase 2
Moderately Hypo-fractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038332 — Phase 2
~62 spots leftby Nov 2026