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

NCT03561220 | Active Not Recruiting DMC

• 4 other identifiers: COMPPAREPCORI-6312IRB201801001OCR17881
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 53

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Proton Radiation; Photon Radiation; Cancer of the Prostate

Outcome Measures

Primary Outcomes (1)

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

  EPIC assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Factor analysis supports dividing the Urinary Domain Summary Score into two distinct Incontinence and Irritative/Obstructive subscales. In addition, each Domain Summary Score has measurable Function Subscale and Bother Subscale components. Response options for each EPIC item form a Likert scale, and multi-item scale scores are components. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL

  2-years after the end of radiation therapy

Secondary Outcomes (3)

• Grade 2 or higher toxicity for each adverse event assessed by CTCAE

  2-years after the end of radiation therapy

• Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE.

  2-years after the end of radiation therapy

• Freedom from biochemical progression using PSA results.

  3-years after the end of radiation therapy

Study Arms (4)

IMRT (Photon)

ACTIVE COMPARATOR

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

Radiation: Standard of Care IMRT (Photon)

Proton Therapy Standard of Care

ACTIVE COMPARATOR

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

Radiation: Standard of Care Proton Therapy

Standard Proton Therapy

EXPERIMENTAL

78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.

Radiation: Proton Arm 1: Standard Proton Therapy

Hypofractionated Proton therapy

EXPERIMENTAL

60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.

Radiation: Proton Arm 2: Hypofractionated Proton Therapy

Interventions

Standard of Care IMRT (Photon) RADIATION

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

IMRT (Photon)

Standard of Care Proton Therapy RADIATION

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

Proton Therapy Standard of Care

Proton Arm 1: Standard Proton Therapy RADIATION

78.0 Gy (RBE) in 39 fractions

Standard Proton Therapy

Proton Arm 2: Hypofractionated Proton Therapy RADIATION

60.0 Gy (RBE) in 20 fractions

Hypofractionated Proton therapy

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of adenocarcinoma of the prostate.
• 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).

You may not qualify if:

• Findings of metastatic disease (nodal or distant, N1 or M1).
• 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.

Sponsors & Collaborators

• University of Florida: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (53)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Proton Therapy Treatment Center - Loma Linda University

Loma Linda, California, 92354, United States

Location

Sutter Health

Roseville, California, 95661, United States

Location

California Protons Cancer Therapy Center

San Diego, California, 92121, United States

Location

Department of Radiation Oncology Davis Cancer Pavilion

Gainesville, Florida, 32611, United States

Location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Ackerman Cancer Center

Jacksonville, Florida, 32223, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Orlando Health UF Health Center

Orlando, Florida, 32806, United States

Location

Winship Cancer Institute - Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Northwestern Medicine Proton Center

Warrenville, Illinois, 60555, United States

Location

University of Kansas Medical Center

Lawrence, Kansas, 66045, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Willis-Knighton Medical Center PTC

Shreveport, Louisiana, 71103, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

University of Maryland

College Park, Maryland, 20742, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic Health System

Mankato, Minnesota, 56001, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

S Lee Kling Proton Therapy Center - Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Covenant Health

Somerset, New Jersey, 08873, United States

Location

New York Proton Center

New York, New York, 10035, United States

Location

Weill Cornell

New York, New York, 10065, United States

Location

The Duke University Health System

Durham, North Carolina, 27705, United States

Location

UNC- Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

University of Cincinnati Medical PTC

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

University Hospitals- Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

University of Pennsylvania--Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19144, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Location

Covenant Health Proton Center

Knoxville, Tennessee, 37909, United States

Location

Texas Oncology

Austin, Texas, 78731, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Center for Proton Therapy

Irving, Texas, 75063, United States

Location

Texas Oncology - Longview

Longview, Texas, 75601, United States

Location

Texas Oncology - McKinney

McKinney, Texas, 75071, United States

Location

Texas Oncology - Plano West

Plano, Texas, 75093, United States

Location

Texas Oncology - Waco

Waco, Texas, 76712, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Hampton University Proton Therapy Institute

Hampton, Virginia, 23666, United States

Location

Seattle Care Alliance/University of Washington

Seattle, Washington, 98133, United States

Location

Mayo Clinic Health System

Eau Claire, Wisconsin, 54703, United States

Location

Mayo Clinic Health System-Franciscan Healthcare

Sparta, Wisconsin, 54656, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Photons

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Elementary Particles; Physical Phenomena; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Officials

• Nancy P. Mendenhall, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 19, 2018
• Study Start: July 5, 2018
• Primary Completion: February 15, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (53)