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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care IMRT (Photon)
Standard of Care Proton Therapy
Proton Arm 1: Standard Proton Therapy
Proton Arm 2: Hypofractionated Proton Therapy
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Proton Radiation, Photon Radiation, Cancer of the Prostate

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham (UAB)
  • University of Arizona
  • University of California San Diego
  • Proton Therapy Treatment Center - Loma Linda University
  • Kaiser Permanente
  • Sutter Health
  • California Protons Cancer Therapy Center
  • Department of Radiation Oncology Davis Cancer Pavilion
  • University of Florida Proton Therapy Institute
  • Ackerman Cancer Center
  • Mayo Clinic
  • University of Miami School of Medicine
  • Miami Cancer Institute
  • Orlando Health UF Health Center
  • Winship Cancer Institute - Emory University
  • University of Chicago
  • Northwestern Medicine Proton Center
  • University of Kansas Medical Center
  • University of Louisville
  • Willis-Knighton Medical Center PTC
  • Johns Hopkins University
  • University of Maryland
  • Massachusetts General Hospital
  • Karmanos Cancer Institute
  • Mayo Clinic Health System
  • Mayo Clinic
  • S Lee Kling Proton Therapy Center - Washington University Medical Center
  • Rutgers Cancer Institute of New Jersey
  • ProCure Proton Therapy Center
  • New York Proton Center
  • Weill Cornell
  • The Duke University Health System
  • UNC- Rex Hospital
  • University of Cincinnati Medical PTC
  • Cleveland Clinic
  • University Hospitals- Seidman Cancer Center
  • Stephenson Cancer Center
  • Oregon Health & Science University
  • University of Pennsylvania--Penn Medicine
  • Thomas Jefferson University
  • Medical University of South Carolina
  • Mabry Center for Cancer Care
  • Provision CARES Proton Therapy Center Knoxville
  • Texas Oncology
  • University of Texas MD Anderson Cancer Center
  • Texas Center for Proton Therapy
  • Texas Oncology - Longview
  • Texas Oncology - McKinney
  • Texas Oncology - Plano West
  • Texas Oncology - Waco
  • University of Virginia
  • Inova Schar Cancer Institute
  • Hampton University Proton Therapy Institute
  • Seattle Care Alliance/University of Washington
  • Mayo Clinic Health System
  • Mayo Clinic Health System-Franciscan Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

IMRT (Photon)

Proton Therapy Standard of Care

Standard Proton Therapy

Hypofractionated Proton therapy

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
May 15, 2018
Last Updated
May 9, 2023
Sponsor
University of Florida
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03561220
Brief Title
A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
Acronym
COMPPARE
Official Title
A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
February 15, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Proton Radiation, Photon Radiation, Cancer of the Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMRT (Photon)
Arm Type
Active Comparator
Arm Description
As this trial is pragmatic, all treatment will be standard of care.
Arm Title
Proton Therapy Standard of Care
Arm Type
Active Comparator
Arm Description
As this trial is pragmatic, all treatment will be standard of care.
Arm Title
Standard Proton Therapy
Arm Type
Experimental
Arm Description
78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
Arm Title
Hypofractionated Proton therapy
Arm Type
Experimental
Arm Description
60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.
Intervention Type
Radiation
Intervention Name(s)
Standard of Care IMRT (Photon)
Intervention Description
As this trial is pragmatic, all treatment will be standard of care.
Intervention Type
Radiation
Intervention Name(s)
Standard of Care Proton Therapy
Intervention Description
As this trial is pragmatic, all treatment will be standard of care.
Intervention Type
Radiation
Intervention Name(s)
Proton Arm 1: Standard Proton Therapy
Intervention Description
78.0 Gy (RBE) in 39 fractions
Intervention Type
Radiation
Intervention Name(s)
Proton Arm 2: Hypofractionated Proton Therapy
Intervention Description
60.0 Gy (RBE) in 20 fractions
Primary Outcome Measure Information:
Title
Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores
Description
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
Time Frame
2-years after the end of radiation therapy
Secondary Outcome Measure Information:
Title
Grade 2 or higher toxicity for each adverse event assessed by CTCAE
Description
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.
Time Frame
2-years after the end of radiation therapy
Title
Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE.
Description
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.
Time Frame
2-years after the end of radiation therapy
Title
Freedom from biochemical progression using PSA results.
Description
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).
Time Frame
3-years after the end of radiation therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy P. Mendenhall, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Proton Therapy Treatment Center - Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Sutter Health
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
California Protons Cancer Therapy Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Department of Radiation Oncology Davis Cancer Pavilion
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of Florida Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
Ackerman Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32223
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Orlando Health UF Health Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Winship Cancer Institute - Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Northwestern Medicine Proton Center
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
University of Kansas Medical Center
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
Willis-Knighton Medical Center PTC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Health System
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
S Lee Kling Proton Therapy Center - Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
ProCure Proton Therapy Center
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
New York Proton Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
The Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
UNC- Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
University of Cincinnati Medical PTC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University Hospitals- Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
University of Pennsylvania--Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19144
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Mabry Center for Cancer Care
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Provision CARES Proton Therapy Center Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Texas Oncology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Center for Proton Therapy
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Texas Oncology - Longview
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Texas Oncology - McKinney
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Texas Oncology - Plano West
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Texas Oncology - Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Hampton University Proton Therapy Institute
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Seattle Care Alliance/University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Mayo Clinic Health System
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54703
Country
United States
Facility Name
Mayo Clinic Health System-Franciscan Healthcare
City
Sparta
State/Province
Wisconsin
ZIP/Postal Code
54656
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer

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