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

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT03561220
Collaborator
Patient-Centered Outcomes Research Institute (Other)
3,000
57
4
92.9
52.6
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 5, 2018
Anticipated Primary Completion Date :
Feb 15, 2026
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores [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 [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. [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. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham (UAB) Birmingham Alabama United States 35294
2 University of Arizona Tucson Arizona United States 85724
3 University of California San Diego La Jolla California United States 92093
4 Proton Therapy Treatment Center - Loma Linda University Loma Linda California United States 92354
5 Kaiser Permanente Los Angeles California United States 90027
6 Sutter Health Roseville California United States 95661
7 California Protons Cancer Therapy Center San Diego California United States 92121
8 Department of Radiation Oncology Davis Cancer Pavilion Gainesville Florida United States 32611
9 University of Florida Proton Therapy Institute Jacksonville Florida United States 32206
10 Ackerman Cancer Center Jacksonville Florida United States 32223
11 Mayo Clinic Jacksonville Florida United States 32224
12 University of Miami School of Medicine Miami Florida United States 33136
13 Miami Cancer Institute Miami Florida United States 33176
14 Orlando Health UF Health Center Orlando Florida United States 32806
15 Winship Cancer Institute - Emory University Atlanta Georgia United States 30322
16 University of Chicago Chicago Illinois United States 60637
17 Northwestern Medicine Proton Center Warrenville Illinois United States 60555
18 University of Kansas Medical Center Lawrence Kansas United States 66045
19 University of Louisville Louisville Kentucky United States 40292
20 Willis-Knighton Medical Center PTC Shreveport Louisiana United States 71103
21 Johns Hopkins University Baltimore Maryland United States 21218
22 University of Maryland College Park Maryland United States 20742
23 Massachusetts General Hospital Boston Massachusetts United States 02114
24 Karmanos Cancer Institute Detroit Michigan United States 48201
25 Mayo Clinic Health System Mankato Minnesota United States 56001
26 Mayo Clinic Rochester Minnesota United States 55905
27 S Lee Kling Proton Therapy Center - Washington University Medical Center Saint Louis Missouri United States 63110
28 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
29 ProCure Proton Therapy Center Somerset New Jersey United States 08873
30 New York Proton Center New York New York United States 10035
31 Weill Cornell New York New York United States 10065
32 The Univeristy of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
33 The Duke University Health System Durham North Carolina United States 27705
34 UNC- Rex Hospital Raleigh North Carolina United States 27607
35 University of Cincinnati Medical PTC Cincinnati Ohio United States 45267
36 Cleveland Clinic Cleveland Ohio United States 44106
37 University Hospitals- Seidman Cancer Center Cleveland Ohio United States 44106
38 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
39 Oregon Health & Science University Portland Oregon United States 97201
40 University of Pennsylvania--Penn Medicine Philadelphia Pennsylvania United States 19104
41 Thomas Jefferson University Philadelphia Pennsylvania United States 19144
42 Medical University of South Carolina Charleston South Carolina United States 29407
43 Mabry Center for Cancer Care Orangeburg South Carolina United States 29118
44 Provision CARES Proton Therapy Center Knoxville Knoxville Tennessee United States 37909
45 Texas Oncology Austin Texas United States 78731
46 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
47 Texas Center for Proton Therapy Irving Texas United States 75063
48 Texas Oncology - Longview Longview Texas United States 75601
49 Texas Oncology - McKinney McKinney Texas United States 75071
50 Texas Oncology - Plano West Plano Texas United States 75093
51 Texas Oncology - Waco Waco Texas United States 76712
52 University of Virginia Charlottesville Virginia United States 22904
53 Inova Schar Cancer Institute Fairfax Virginia United States 22031
54 Hampton University Proton Therapy Institute Hampton Virginia United States 23666
55 Seattle Care Alliance/University of Washington Seattle Washington United States 98133
56 Mayo Clinic Health System Eau Claire Wisconsin United States 54703
57 Mayo Clinic Health System-Franciscan Healthcare Sparta Wisconsin United States 54656

Sponsors and Collaborators

  • University of Florida
  • Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Nancy P. Mendenhall, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT03561220
Other Study ID Numbers:
  • COMPPARE
  • PCORI-6312
  • IRB201801001
  • OCR17881
First Posted:
Jun 19, 2018
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022