A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer (COMPPARE)
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| ClinicalTrials.gov Identifier: NCT03561220 |
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Recruitment Status :
Active, not recruiting
First Posted : June 19, 2018
Last Update Posted : May 10, 2023
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Sponsor:
University of Florida
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Florida
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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 |
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 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 : | February 15, 2026 |
| Estimated Study Completion Date : | April 1, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: IMRT (Photon)
As this trial is pragmatic, all treatment will be standard of care.
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Radiation: Standard of Care IMRT (Photon)
As this trial is pragmatic, all treatment will be standard of care. |
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Active Comparator: Proton Therapy Standard of Care
As this trial is pragmatic, all treatment will be standard of care.
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Radiation: Standard of Care Proton Therapy
As this trial is pragmatic, all treatment will be standard of care. |
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Experimental: Standard Proton Therapy
78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
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Radiation: Proton Arm 1: Standard Proton Therapy
78.0 Gy (RBE) in 39 fractions |
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Experimental: Hypofractionated Proton therapy
60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.
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Radiation: Proton Arm 2: Hypofractionated Proton Therapy
60.0 Gy (RBE) in 20 fractions |
Primary Outcome Measures :
- Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item 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 :
- 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).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 30 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
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
Locations
Show 56 study locations
Sponsors and Collaborators
University of Florida
Patient-Centered Outcomes Research Institute
Investigators
| Principal Investigator: | Nancy P. Mendenhall, MD | University of Florida |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT03561220 |
| 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: | May 10, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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Prostate Cancer Proton Radiation Photon Radiation Cancer of the Prostate |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |