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

Prostate Cancer Clinical Trial

— COMPPARE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03561220
• Other study ID #: COMPPARE
• Secondary ID: PCORI-6312IRB201
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: April 1, 2026

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: April 1, 2026
• Est. primary completion date: February 15, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosis of adenocarcinoma of the prostate.
• 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:

• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
United States	Winship Cancer Institute - Emory University	Atlanta	Georgia
United States	Texas Oncology	Austin	Texas
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
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	University of Maryland	College Park	Maryland
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	The Duke University Health System	Durham	North Carolina
United States	Mayo Clinic Health System	Eau Claire	Wisconsin
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Department of Radiation Oncology Davis Cancer Pavilion	Gainesville	Florida
United States	Hampton University Proton Therapy Institute	Hampton	Virginia
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Texas Center for Proton Therapy	Irving	Texas
United States	Ackerman Cancer Center	Jacksonville	Florida
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida
United States	Provision CARES Proton Therapy Center Knoxville	Knoxville	Tennessee
United States	University of California San Diego	La Jolla	California
United States	University of Kansas Medical Center	Lawrence	Kansas
United States	Proton Therapy Treatment Center - Loma Linda University	Loma Linda	California
United States	Texas Oncology - Longview	Longview	Texas
United States	Kaiser Permanente	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Mayo Clinic Health System	Mankato	Minnesota
United States	Texas Oncology - McKinney	McKinney	Texas
United States	Miami Cancer Institute	Miami	Florida
United States	University of Miami School of Medicine	Miami	Florida
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	New York Proton Center	New York	New York
United States	Weill Cornell	New York	New York
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Mabry Center for Cancer Care	Orangeburg	South Carolina
United States	Orlando Health UF Health Center	Orlando	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania--Penn Medicine	Philadelphia	Pennsylvania
United States	Texas Oncology - Plano West	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	UNC- Rex Hospital	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Sutter Health	Roseville	California
United States	S Lee Kling Proton Therapy Center - Washington University Medical Center	Saint Louis	Missouri
United States	California Protons Cancer Therapy Center	San Diego	California
United States	Seattle Care Alliance/University of Washington	Seattle	Washington
United States	Willis-Knighton Medical Center PTC	Shreveport	Louisiana
United States	ProCure Proton Therapy Center	Somerset	New Jersey
United States	Mayo Clinic Health System-Franciscan Healthcare	Sparta	Wisconsin
United States	University of Arizona	Tucson	Arizona
United States	Texas Oncology - Waco	Waco	Texas
United States	Northwestern Medicine Proton Center	Warrenville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Grade 2 or higher toxicity for each adverse event assessed by CTCAE	The NCI Common Terminology Criteria for Adverse Events v5.0 is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.	2-years after the end of radiation therapy
Secondary	Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE.	PRO-CTCAE responses are scored from 0 to 4, and there are as yet no standardized scoring rules for how to combine attributes into a single score or how best to analyse PRO-CTCAE data longitudinally. PRO-CTCAE scores for each attribute (frequency, severity and/or interference) should be presented descriptively (e.g. summary statistics or graphical presentations). CTCAE grades for the corresponding time period should be presented in conjunction with PRO-CTCAE scores.	2-years after the end of radiation therapy
Secondary	Freedom from biochemical progression using PSA results.	Biochemical failure is defined as a sustained rise in PSA of 2 ng/mL or more above the nadir (the lowest PSA level after radiotherapy).	3-years after the end of radiation therapy