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

Trial Status: Active

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.

Inclusion Criteria

  • Diagnosis of adenocarcinoma of the prostate.
  • Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE, and clinical stage.
  • Very low-risk, Low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines1 and Joint AUA/ASTRO/SUO Guidelines.51
  • If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones.
  • 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).
  • No previous prostate cancer treatment with the exception of ADT according to NCCN guidelines.
  • 30-85 years of age at the time of consent with a life expectancy estimation (LEE) of ≥8 years.
  • ECOG/Zubrod Performance Status 0 - 2.

Exclusion Criteria

  • Findings of metastatic disease (nodal or distant, N1 or M1).
  • Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines1 and Joint AUA/ASTRO/SUO Guidelines.51
  • Prior prostate surgical procedure
  • History of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
  • 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.

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Andrew Michael McDonald
Phone: 205-996-5669

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

California

San Diego
University of California San Diego
Status: ACTIVE

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: ACTIVE
Contact: Nancy Price Mendenhall
Phone: 904-588-1800
Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory Proton Therapy Center
Status: ACTIVE
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Christopher Baierl
Phone: 913-588-3671

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Minnesota

Mankato
Mayo Clinic Health Systems-Mankato
Status: ACTIVE
Rochester
Mayo Clinic in Rochester
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Wisconsin

Eau Claire
Mayo Clinic Health System-Eau Claire Clinic
Status: ACTIVE
La Crosse
Mayo Clinic Health System-Franciscan Healthcare
Status: ACTIVE

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. Pre-specified subset comparators

include a randomized comparison of standard fractionation and moderate hypofractionation dose

schemes within the proton therapy cohort. In addition, analysis of heterogeneous treatment

effects (HTE) will include a comparison of outcomes by race (Black vs. White), comorbidity

score (0 vs. 1+), age (≤65 vs. >65), and prostate cancer aggressiveness (low, intermediate,

and high risk) for all endpoints.

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.

Trial Phase Phase NA

Trial Type Treatment

Lead Organization
University of Florida Health Science Center - Gainesville

  • Primary ID COMPPARE
  • Secondary IDs NCI-2019-03800, PCORI-6312, IRB201801001, OCR17881
  • Clinicaltrials.gov ID NCT03561220