Protocol No.: OCR17881
Sponsor Protocol No.: UF-GU-002; COMPPARE
Protocol Title.: A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
Principal Investigator: Mendenhall, Nancy
Objective: 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.
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. Pre-specified subset comparators include a randomized comparison of standard fractionation and moderate hypofractionation dose schemes within the proton therapy cohort. In addition, analysis of heterogeneous treatment effects (HTE) will include a comparison of outcomes by race (Black vs. White), comorbidity score (0 vs. 1+), age (≤65 vs. >65), and prostate cancer aggressiveness (low, intermediate, and high risk) for all endpoints. 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.
Phase: Phase III (Cancer Control)
Age Group: Adult
Age: 30 Years - 85 Years
Active Comparator: IMRT (Photon)As this trial is pragmatic, all treatment will be standard of care.
Active Comparator: Proton Therapy Standard of CareAs this trial is pragmatic, all treatment will be standard of care.
Experimental: Standard Proton Therapy78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
Experimental: Hypofractionated Proton therapy60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.
Detailed Eligibility: Inclusion Criteria: - Diagnosis of adenocarcinoma of the prostate. - Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE, and clinical stage. - Very low-risk, Low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines1 and Joint AUA/ASTRO/SUO Guidelines.51 - If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones. - 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). - No previous prostate cancer treatment with the exception of ADT according to NCCN guidelines. - 30-85 years of age at the time of consent with a life expectancy estimation (LEE) of ≥8 years. - ECOG/Zubrod Performance Status 0 - 2. Exclusion Criteria: - Findings of metastatic disease (nodal or distant, N1 or M1). - Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines1 and Joint AUA/ASTRO/SUO Guidelines.51 - Prior prostate surgical procedure - History of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval. - 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, as well as, Gleason 5+4 or 5+5 are not eligible .