A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
NCT ID: NCT03561220
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
3000 participants
INTERVENTIONAL
2018-07-05
2026-04-01
Brief Summary
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Detailed Description
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All interventions will be standard of care (SOC) radiation strategies using either IMRT or proton therapy. All patient-reported QOL, patient-scored and patient-reported toxicity, and disease control assessments will be SOC. Participants will also complete pretreatment surveys regarding demographic data, personal treatment goals, factors affecting treatment decision-making, and sources of information used in treatment selection.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMRT (Photon)
As this trial is pragmatic, all treatment will be standard of care.
Standard of Care IMRT (Photon)
As this trial is pragmatic, all treatment will be standard of care.
Proton Therapy Standard of Care
As this trial is pragmatic, all treatment will be standard of care.
Standard of Care Proton Therapy
As this trial is pragmatic, all treatment will be standard of care.
Standard Proton Therapy
78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
Proton Arm 1: Standard Proton Therapy
78.0 Gy (RBE) in 39 fractions
Hypofractionated Proton therapy
60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.
Proton Arm 2: Hypofractionated Proton Therapy
60.0 Gy (RBE) in 20 fractions
Interventions
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Standard of Care IMRT (Photon)
As this trial is pragmatic, all treatment will be standard of care.
Standard of Care Proton Therapy
As this trial is pragmatic, all treatment will be standard of care.
Proton Arm 1: Standard Proton Therapy
78.0 Gy (RBE) in 39 fractions
Proton Arm 2: Hypofractionated Proton Therapy
60.0 Gy (RBE) in 20 fractions
Eligibility Criteria
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Inclusion Criteria
* 30-85 years of age at the time of consent with a life expectancy estimation (LEE) of ≥ 8 years.
* Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE with or without mpMRI, and clinical stage.
* Very low-risk, low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.
* If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones.
* ECOG/Zubrod Performance Status 0 - 2.
* Candidate for definitive prostate radiotherapy (either IMRT or proton).
* If patient is to be treated with IMRT, all treatment must be planned with IMRT; if patient is to be treated with protons, all treatment must be planned with protons (including pelvic nodes if treated).
Exclusion Criteria
* Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.
* Prior procedures for treatment of prostate cancer, such as radical or robotic prostatectomy, high-intensity focused ultrasound, cryosurgery, or focal prostatectomy \[note that procedures used for benign prostatic hyperplasia symptoms, such as transurethral resection of the prostate (TURP) and GreenLight Laser Therapy, are acceptable\].
* Previous prostate cancer treatment with the exception of ADT according to NCCN guidelines.
* History of invasive rectal malignancy or other malignancy in the true pelvis (e.g. bladder, rectum, or reproductive organs), regardless of disease-free interval.
* Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic).
* Prior pelvic RT for any reason.
* Documented lack of psychological ability or general health permitting completion of the study requirements and required follow-up.
* Documented diminished capacity to understand the risks and benefits of participation in research and to autonomously provide informed consent.
In addition, because the embedded randomized controlled trial compares fractionation schemes, patients who are receiving pelvic node irradiation may not be enrolled on the randomized controlled trial.
30 Years
85 Years
MALE
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Nancy P. Mendenhall, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
University of California San Diego
La Jolla, California, United States
Proton Therapy Treatment Center - Loma Linda University
Loma Linda, California, United States
Sutter Health
Roseville, California, United States
California Protons Cancer Therapy Center
San Diego, California, United States
Department of Radiation Oncology Davis Cancer Pavilion
Gainesville, Florida, United States
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Ackerman Cancer Center
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Orlando Health UF Health Center
Orlando, Florida, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Northwestern Medicine Proton Center
Warrenville, Illinois, United States
University of Kansas Medical Center
Lawrence, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Willis-Knighton Medical Center PTC
Shreveport, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Maryland
College Park, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Health System
Mankato, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
S Lee Kling Proton Therapy Center - Washington University Medical Center
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Covenant Health
Somerset, New Jersey, United States
New York Proton Center
New York, New York, United States
Weill Cornell
New York, New York, United States
The Duke University Health System
Durham, North Carolina, United States
UNC- Rex Hospital
Raleigh, North Carolina, United States
University of Cincinnati Medical PTC
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospitals- Seidman Cancer Center
Cleveland, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania--Penn Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Provision CARES Proton Therapy Center Knoxville
Knoxville, Tennessee, United States
Texas Oncology
Austin, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Center for Proton Therapy
Irving, Texas, United States
Texas Oncology - Longview
Longview, Texas, United States
Texas Oncology - McKinney
McKinney, Texas, United States
Texas Oncology - Plano West
Plano, Texas, United States
Texas Oncology - Waco
Waco, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Hampton University Proton Therapy Institute
Hampton, Virginia, United States
Seattle Care Alliance/University of Washington
Seattle, Washington, United States
Mayo Clinic Health System
Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare
Sparta, Wisconsin, United States
Countries
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References
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NCCN Clinical Practical Guidelines in Oncology: Prostate Cancer. Version 2. 2018.
AJCC Cancer Staging Manual. 8th ed. Cham, Switzerland: Springer International Publishing; 2017.
Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
U.S. Preventive Services Task Force. Draft Recommendation Statement: Prostate Cancer: Screening. April 2017; https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementDraft/prostate-cancer-screening1. Accessed May 8, 2017.
Chen RC, Clark JA, Talcott JA. Individualizing quality-of-life outcomes reporting: how localized prostate cancer treatments affect patients with different levels of baseline urinary, bowel, and sexual function. J Clin Oncol. 2009 Aug 20;27(24):3916-22. doi: 10.1200/JCO.2008.18.6486. Epub 2009 Jul 20.
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Stokes ME, Ishak J, Proskorovsky I, Black LK, Huang Y. Lifetime economic burden of prostate cancer. BMC Health Serv Res. 2011 Dec 28;11:349. doi: 10.1186/1472-6963-11-349.
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Other Identifiers
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PCORI-6312
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB201801001
Identifier Type: OTHER
Identifier Source: secondary_id
OCR17881
Identifier Type: OTHER
Identifier Source: secondary_id
COMPPARE
Identifier Type: -
Identifier Source: org_study_id
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