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

Open to males ages 30-85

• 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.

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 .