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ACTIVE NOT RECRUITING
NCT03561220
NA

A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes \[quality of life (QOL), toxicity, and disease control\] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques.

Key Details

Gender

MALE

Age Range

30 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2018-07-05

Completion Date

2027-07-01

Last Updated

2026-03-09

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Standard of Care IMRT (Photon)

As this trial is pragmatic, all treatment will be standard of care.

RADIATION

Standard of Care Proton Therapy

As this trial is pragmatic, all treatment will be standard of care.

RADIATION

Proton Arm 1: Standard Proton Therapy

78.0 Gy (RBE) in 39 fractions

RADIATION

Proton Arm 2: Hypofractionated Proton Therapy

60.0 Gy (RBE) in 20 fractions

Locations (53)

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

Covenant Health Proton Center

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