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 : January 5, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE July 5, 2018
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2018)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
Official Title  ICMJE A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
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. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: Standard of Care IMRT (Photon)
    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.
  • Radiation: Proton Arm 1: Standard Proton Therapy
    78.0 Gy (RBE) in 39 fractions
  • Radiation: Proton Arm 2: Hypofractionated Proton Therapy
    60.0 Gy (RBE) in 20 fractions
Study Arms  ICMJE
  • Active Comparator: IMRT (Photon)
    As this trial is pragmatic, all treatment will be standard of care.
    Intervention: Radiation: Standard of Care IMRT (Photon)
  • Active Comparator: Proton Therapy Standard of Care
    As this trial is pragmatic, all treatment will be standard of care.
    Intervention: Radiation: Standard of Care Proton Therapy
  • Experimental: Standard Proton Therapy
    78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
    Intervention: Radiation: Proton Arm 1: Standard Proton Therapy
  • Experimental: Hypofractionated Proton therapy
    60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.
    Intervention: Radiation: Proton Arm 2: Hypofractionated Proton Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2018)		 3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2023
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: COMPPARE Study Team 904-588-1800 comppare-admin@ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03561220
Other Study ID Numbers  ICMJE COMPPARE
PCORI-6312 ( Other Grant/Funding Number: PCORI )
IRB201801001 ( Other Identifier: University of Florida )
OCR17881 ( Other Identifier: University of Florida )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Nancy P. Mendenhall, MD University of Florida
PRS Account University of Florida
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP