A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Standard of Care Proton TherapyRadiation: Standard of Care IMRT (Photon)
- Registration Number
- NCT03561220
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 3000
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Proton Therapy Standard of Care Standard of Care Proton Therapy As this trial is pragmatic, all treatment will be standard of care. IMRT (Photon) Standard of Care IMRT (Photon) As this trial is pragmatic, all treatment will be standard of care.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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).
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.
Trial Locations
- Locations (54)
Department of Radiation Oncology Davis Cancer Pavilion
🇺🇸Gainesville, Florida, United States
Northwestern Medicine Proton Center
🇺🇸Warrenville, Illinois, United States
Ackerman Cancer Center
🇺🇸Jacksonville, Florida, United States
Proton Therapy Treatment Center - Loma Linda University
🇺🇸Loma Linda, California, United States
Willis-Knighton Medical Center PTC
🇺🇸Shreveport, Louisiana, United States
University of Maryland
🇺🇸College Park, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
S Lee Kling Proton Therapy Center - Washington University Medical Center
🇺🇸Saint Louis, Missouri, United States
New York Proton Center
🇺🇸New York, New York, United States
UNC- Rex Hospital
🇺🇸Raleigh, North Carolina, United States
Winship Cancer Institute - Emory University
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Sutter Health
🇺🇸Roseville, California, United States
University of Florida Proton Therapy Institute
🇺🇸Jacksonville, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Mabry Center for Cancer Care
🇺🇸Orangeburg, South Carolina, United States
Texas Oncology
🇺🇸Austin, Texas, United States
Provision CARES Proton Therapy Center Knoxville
🇺🇸Knoxville, Tennessee, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology - Longview
🇺🇸Longview, Texas, United States
Texas Oncology - McKinney
🇺🇸McKinney, Texas, United States
Texas Oncology - Waco
🇺🇸Waco, Texas, United States
Texas Oncology - Plano West
🇺🇸Plano, Texas, United States
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
Hampton University Proton Therapy Institute
🇺🇸Hampton, Virginia, United States
Mayo Clinic Health System-Franciscan Healthcare
🇺🇸Sparta, Wisconsin, United States
Miami Cancer Institute
🇺🇸Miami, Florida, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Seattle Care Alliance/University of Washington
🇺🇸Seattle, Washington, United States
University of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
University of Cincinnati Medical PTC
🇺🇸Cincinnati, Ohio, United States
California Protons Cancer Therapy Center
🇺🇸San Diego, California, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Mayo Clinic Health System
🇺🇸Eau Claire, Wisconsin, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
ProCure Proton Therapy Center
🇺🇸Somerset, New Jersey, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
The Duke University Health System
🇺🇸Durham, North Carolina, United States
Weill Cornell
🇺🇸New York, New York, United States
University of Pennsylvania--Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States
University Hospitals- Seidman Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Orlando Health UF Health Center
🇺🇸Orlando, Florida, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Texas Center for Proton Therapy
🇺🇸Irving, Texas, United States
University of Kansas Medical Center
🇺🇸Lawrence, Kansas, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States