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

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ClinicalTrials.gov Identifier: NCT03561220
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : August 14, 2018
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 Device: Standard of Care IMRT (Photon) Device: Standard of Care Proton Therapy Device: Proton Arm 1: Standard Proton Therapy Device: 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.


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.
Device: 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.
Device: 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.
Device: 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.
Device: 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

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

Inclusion Criteria:

  • Candidate for definitive prostate radiotherapy (either IMRT or proton).
  • Patients to be treated with IMRT should have all treatment planned with IMRT; patients to be treated with protons should have all treatment planned with protons (including pelvic nodes if treated).
  • Men diagnosed with adenocarcinoma of the prostate who have not received previous treatment with the exception of short-term (≤6 months) ADT according to NCCN guidelines (Appendix 6).
  • Localized prostate cancer, as confirmed by staging (Appendices 1 and 2) with PSA, biopsy, Gleason score, DRE, and clinical stage.
  • Nuclear medicine bone imaging is required for confirmation of the absence of overt metastatic disease in bones if any high-risk criteria are identified [clinical stage T3A; or ≤4 cores of Gleason score 8 (NCCN grade group 4) or 4+5; or PSA ≥20 ng/mL].
  • Diagnosed with NCCN Risk Groups 1-4 low-risk; intermediate-risk; or high-risk disease that is characterized by only one of the following criteria: clinical stage T3A; or ≤4 cores of Gleason score 8 (NCCN grade group 4) or 4+5; or PSA ≥20 ng/mL.
  • 30-80 years of age at the time of consent with a life expectancy of ≥10 years.
  • ECOG/Zubrod Performance Status 0 - 2.

Exclusion Criteria:

  • Findings of metastatic disease (nodal or distant, N1 or M1).
  • Subset of NCCN Group 1 with very low-risk prostate cancer: T1c; and Gleason score ≤6 or NCCN grade group 1; and PSA <10 ng/mL; and fewer than 3 positive prostate biopsy cores; and ≤50% cancer in all positive cores; and PSA density <0.15 ng/mL/g.
  • NCCN very high-risk prostate cancer: T3b-T4; or Primary Gleason pattern 5; or >4 cores with Gleason score 8-10 (NCCN grade group 4 or 5).
  • 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 decisionally impaired persons who have a diminished capacity to understand the risks and benefits of participation in research and to autonomously provide informed consent.

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
Contact: COMPPARE Study Team 904-588-1800 comppare-admin@ufl.edu

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Nancy P Mendenhall, MD         
Sponsors and Collaborators
University of Florida
Patient-Centered Outcomes Research Institute
Investigators
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.

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: UF IRB )
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Prostate Cancer
Proton Radiation
Photon Radiation
Cancer of the Prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases