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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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

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I can provide tissue from my prostate surgery for review.

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It has been 6 months or more since my prostate surgery.

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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.

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I am mostly able to care for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

294 Previous Clinical Trials

23,985 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

$Moderately Hypo-fractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05038332 — Phase 2$

$Prostate Cancer Research Study Groups: Moderately Hypo-fractionated Radiation Therapy, Ultra-Hypofractionated Radiation Therapy$

$Prostate Cancer Clinical Trial 2023: Moderately Hypo-fractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT05038332 — Phase 2$

$Moderately Hypo-fractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038332 — Phase 2$

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the greatest number of participants allowed in this clinical research protocol?

"Affirmative. Details available on clinicaltrials.gov report that this medical experiment, first advertised on November 12th 2021, is currently enrolling participants from 1 trial site with a target of 136 patients in total."

Answered by AI

Has Ultra-hypofractionated radiation therapy been given the stamp of approval by the FDA?

"Ultra-hypofractionated radiation therapy is considered moderately safe according to our team at Power, scoring a 2. This evaluation was reached due to the existence of some data on safety but no evidence regarding efficacy in this phase 2 trial."

Answered by AI

Are recruitment efforts ongoing for this research endeavor?

"According to the details provided on clinicaltrials.gov, this study is accepting candidates and was initially posted November 12th 2021 with a recent amendment from December 16th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05038332.