A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
- 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.
- 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.
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.
Trial Phase Phase NA
Trial Type Treatment
University of Florida Health Science Center - Gainesville
- Primary ID COMPPARE
- Secondary IDs NCI-2019-03800, PCORI-6312, IRB201801001, OCR17881
- Clinicaltrials.gov ID NCT03561220