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Proton Beam Therapy

Proton Therapy vs. Photon Radiation for Prostate Cancer (COMPPARE Trial)

N/A
Waitlist Available
Led By Nancy P. Mendenhall, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE with or without mpMRI, and clinical stage
If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones
Must not have
Findings of metastatic disease (nodal or distant, N1 or M1)
Documented diminished capacity to understand the risks and benefits of participation in research and to autonomously provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-years after the end of radiation therapy
Awards & highlights
No Placebo-Only Group

Summary

This trial compares the quality of life, toxicity, and disease control of men with prostate cancer treated with proton therapy vs. IMRT.

Who is the study for?
Men aged 30-85 with localized prostate cancer and a life expectancy of at least 8 years can join. They must have no history of invasive pelvic cancers, prior prostate cancer treatments (except certain therapies for benign conditions), or metastatic disease. Participants need to be physically able to complete the study and give informed consent.
What is being tested?
This trial compares quality of life, toxicity, and disease control between proton therapy and conventional photon-based IMRT in treating prostate cancer. Patients are treated at different facilities but under similar standards to see which method is more effective.
What are the potential side effects?
Potential side effects from both proton therapy and IMRT may include skin reactions, fatigue, digestive issues like diarrhea or nausea, urinary problems such as increased frequency or urgency, and a risk of secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is localized and has been confirmed with specific tests.
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I've had a bone scan to check for cancer spread if my disease is high-risk.
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I have been diagnosed with prostate adenocarcinoma.
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I am between 30 and 85 years old and expected to live 8 more years or longer.
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I am a candidate for specific prostate cancer radiation treatment.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to nearby lymph nodes or other parts of my body.
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I have difficulty understanding the risks and benefits of research studies.
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My prostate cancer is classified as very high-risk.
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I have had cancer in my pelvis area before.
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I have active symptoms of inflammatory bowel disease.
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I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-years after the end of radiation therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-years after the end of radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores
Secondary study objectives
Freedom from biochemical progression using PSA results.
Grade 2 or higher toxicity for each adverse event assessed by CTCAE
Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Standard Proton TherapyExperimental Treatment1 Intervention
78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
Group II: Hypofractionated Proton therapyExperimental Treatment1 Intervention
60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.
Group III: IMRT (Photon)Active Control1 Intervention
As this trial is pragmatic, all treatment will be standard of care.
Group IV: Proton Therapy Standard of CareActive Control1 Intervention
As this trial is pragmatic, all treatment will be standard of care.

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
576 Previous Clinical Trials
27,076,687 Total Patients Enrolled
6 Trials studying Prostate Cancer
19,898 Patients Enrolled for Prostate Cancer
University of FloridaLead Sponsor
1,404 Previous Clinical Trials
763,330 Total Patients Enrolled
11 Trials studying Prostate Cancer
873 Patients Enrolled for Prostate Cancer
Nancy P. Mendenhall, MDPrincipal InvestigatorUniversity of Florida

Media Library

Proton Arm 1: Standard Proton Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03561220 — N/A
Prostate Cancer Research Study Groups: Standard Proton Therapy, Hypofractionated Proton therapy, IMRT (Photon), Proton Therapy Standard of Care
Prostate Cancer Clinical Trial 2023: Proton Arm 1: Standard Proton Therapy Highlights & Side Effects. Trial Name: NCT03561220 — N/A
Proton Arm 1: Standard Proton Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03561220 — N/A
~429 spots leftby Feb 2026
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