A Prospective Comparative Study of Outcomes with Proton and Photon Radiation in Prostate Cancer

Purpose

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 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.

Age

18 to 65
65 and over

Gender

Male

Principal Investigator

Nancy P Mendenhall, M.D.

Sponsoring Group

Department of Radiation Oncology

Department

Department of Radiation Oncology

Contact Information

menden@shands.ufl.edu

904.588.1800


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