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

Prior treatment

• Prior procedures for treatment of prostate cancer, such as radical or robotic prostatectomy, high-intensity focused ultrasound, cryosurgery, or focal prostatectomy \[note that procedures used for benign prostatic hyperplasia symptoms, such as transurethral resection of the prostate (TURP) and GreenLight Laser Therapy, are acceptable\].
• Previous prostate cancer treatment with the exception of ADT according to NCCN guidelines.
• Prior pelvic RT for any reason.
• 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.

Other illness

• Findings of metastatic disease (nodal or distant, N1 or M1).
• Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.
• History of invasive rectal malignancy or other malignancy in the true pelvis (e.g. bladder, rectum, or reproductive organs), regardless of disease-free interval.
• Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic).

Other

• Documented lack of psychological ability or general health permitting completion of the study requirements and required follow-up.

• 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).