Spots Global Cancer Trial Database for A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
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Trial Identification
Brief Title: A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
Official Title: A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
Study ID: NCT03561220
Conditions
Study Description
Brief 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.
Detailed Description: 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. This study includes a pre-specified randomized comparison of standard fractionation and moderate hypofractionation dose schemes within the proton therapy cohort. In addition, subgroup analyses will include a comparison of outcomes by race (Black vs. White), comorbidity score (0 vs. 1+), age (\<65 vs. ≥65), fractionation schedule (standard, moderate, ultra-hypofractionation), and prostate cancer aggressiveness (very low and low, intermediate, and high risk) for all objectives. 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.
Eligibility
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham (UAB), Birmingham, Alabama, United States
University of Arizona, Tucson, Arizona, United States
University of California San Diego, La Jolla, California, United States
Proton Therapy Treatment Center - Loma Linda University, Loma Linda, California, United States
Kaiser Permanente, Los Angeles, 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, Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
ProCure Proton Therapy Center, 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
Mabry Center for Cancer Care, Orangeburg, 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
Contact Details
Name: Nancy P. Mendenhall, MD
Affiliation: University of Florida
Role: PRINCIPAL_INVESTIGATOR
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