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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-years after the end of radiation therapy

Awards & highlights

COMPPARE Trial 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.Check my eligibility

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.See study design

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.

COMPPARE Trial 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.

COMPPARE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-years after the end of radiation therapy

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores

Secondary outcome measures

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.

COMPPARE 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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER

549 Previous Clinical Trials

29,993,776 Total Patients Enrolled

6 Trials studying Prostate Cancer

20,926 Patients Enrolled for Prostate Cancer

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

712,696 Total Patients Enrolled

9 Trials studying Prostate Cancer

818 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

Frequently Asked Questions

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

Are there any openings for those interested in participating in this research?

"This specific medical trial, which was initially launched on July 5th 2018 and modified on November 8th 2022, is no longer seeking participants. However, there are 1,321 other trials that have open recruitment right now."

Answered by AI

Is eligibility for this experiment restricted to individuals aged 45 or below?

"Per the requirements for inclusion, participants must be between 30 and 85 years of age."

Answered by AI

How many establishments have been selected to conduct this experiment?

"This clinical trial has 48 active recruitment sites, including the University of Pennsylvania--Penn Medicine in Philadelphia, Mabry Center for Cancer Care in Orangeburg and Texas Oncology - Plano West in Plano. Additionally, there are 45 other locations where patients can be enrolled."

Answered by AI

To what degree must a patient meet the criteria to register for this clinical investigation?

"The criteria for this medical trial necessitate that candidates have prostate cancer and fall between the ages of 30 to 85. Approximately 3,000 individuals are needed for participation in the experiment."

Answered by AI

Recent research and studies

CA: A Cancer Journal for CliniciansJournal

Cancer Statistics, 2017

Siegel, Rebecca L., Kimberly D. Miller, and Ahmedin Jemal. 2017. “Cancer Statistics, 2017”. CA: A Cancer Journal for Clinicians. Wiley. doi:10.3322/caac.21387.

New England Journal of MedicineJournal

Quality of Life and Satisfaction with Outcome Among Prostate-cancer Survivors

Sanda, Martin G., Rodney L. Dunn, Jeff Michalski, Howard M. Sandler, Laurel Northouse, Larry Hembroff, Xihong Lin, et al.. 2008. “Quality of Life and Satisfaction with Outcome Among Prostate-cancer Survivors”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa074311.

Medical CareJournal

Medicare Payments from Diagnosis to Death for Elderly Cancer Patients by Stage at Diagnosis

Riley, Gerald F., Arnold L. Potosky, James D. Lubitz, and Larry G. Kessler. 1995. “Medicare Payments from Diagnosis to Death for Elderly Cancer Patients by Stage at Diagnosis”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005650-199508000-00007.

European UrologyJournal