Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03561220
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Standard of Care IMRT (Photon) Radiation: Standard of Care Proton Therapy Radiation: Proton Arm 1: Standard Proton Therapy Radiation: Proton Arm 2: Hypofractionated Proton Therapy Not Applicable

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. 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: IMRT (Photon)
As this trial is pragmatic, all treatment will be standard of care.
Radiation: Standard of Care IMRT (Photon)
As this trial is pragmatic, all treatment will be standard of care.

Active Comparator: Proton Therapy Standard of Care
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.

Experimental: Standard Proton Therapy
78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
Radiation: Proton Arm 1: Standard Proton Therapy
78.0 Gy (RBE) in 39 fractions

Experimental: Hypofractionated Proton therapy
60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.
Radiation: Proton Arm 2: Hypofractionated Proton Therapy
60.0 Gy (RBE) in 20 fractions




Primary Outcome Measures :
  1. Bowel, urinary, and sexual dysfunction Expanded Prostate Cancer Index Composite (EPIC) domain scores [ Time Frame: 2-years after the end of radiation therapy ]
    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


Secondary Outcome Measures :
  1. Grade 2 or higher toxicity for each adverse event assessed by CTCAE [ Time Frame: 2-years after the end of radiation therapy ]
    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. Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE. [ Time Frame: 2-years after the end of radiation therapy ]
    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.

  3. Freedom from biochemical progression using PSA results. [ Time Frame: 3-years after the end of radiation therapy ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of adenocarcinoma of the prostate.
  • Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE, and clinical stage.
  • 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.
  • 30-80 years of age at the time of consent with a life expectancy estimation (LEE) of ≥10 years.
  • ECOG/Zubrod Performance Status 0 - 2.

Exclusion Criteria:

  • Findings of metastatic disease (nodal or distant, N1 or M1).
  • Very low-risk or very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines1 and Joint AUA/ASTRO/SUO Guidelines.51
  • Prior prostate surgical procedure, including transurethral resection of the prostate (TURP) and GreenLight Laser Therapy.
  • History of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
  • Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic) or documented history of inflammatory bowel disease requiring intervention.
  • 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, as well as, Gleason 5+4 or 5+5 are not eligible .


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561220


Contacts
Layout table for location contacts
Contact: COMPPARE Study Team 904-588-1800 comppare-admin@ufl.edu

Locations
Layout table for location information
United States, California
California Protons Cancer Therapy Center Recruiting
San Diego, California, United States, 92121
United States, Florida
Department of Radiation Oncology Davis Cancer Pavilion Recruiting
Gainesville, Florida, United States, 32611
Contact: Alesa Flewellen, BS    352-265-8094      
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Nancy P Mendenhall, MD         
Ackerman Cancer Center Recruiting
Jacksonville, Florida, United States, 32223
Orlando Health UF Health Center Recruiting
Orlando, Florida, United States, 32806
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, New Jersey
ProCure Proton Therapy Center Recruiting
Somerset, New Jersey, United States, 08873
United States, New York
New York Proton Center Recruiting
New York, New York, United States, 10035
United States, Pennsylvania
University of Pennsylvania--Penn Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19144
United States, Tennessee
Provision CARES Proton Therapy Center Knoxville Recruiting
Knoxville, Tennessee, United States, 37909
Sponsors and Collaborators
University of Florida
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Nancy P. Mendenhall, MD University of Florida

Publications:
NCCN Clinical Practical Guidelines in Oncology: Prostate Cancer. Version 2. 2018.
AJCC Cancer Staging Manual. 8th ed. Cham, Switzerland: Springer International Publishing; 2017.
U.S. Preventive Services Task Force. Draft Recommendation Statement: Prostate Cancer: Screening. April 2017; https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementDraft/prostate-cancer-screening1. Accessed May 8, 2017.

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03561220     History of Changes
Other Study ID Numbers: COMPPARE
PCORI-6312 ( Other Grant/Funding Number: PCORI )
IRB201801001 ( Other Identifier: University of Florida )
OCR17881 ( Other Identifier: University of Florida )
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Florida:
Prostate Cancer
Proton Radiation
Photon Radiation
Cancer of the Prostate
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases