A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer (COMPPARE)
Prostate Cancer
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
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
Active Comparator
Active Comparator
Experimental
Experimental
IMRT (Photon)
Proton Therapy Standard of Care
Standard Proton Therapy
Hypofractionated Proton therapy
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.