A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
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.
• 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).