A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
Clinical Trial Information
Trial Contact: Manchola-Orozco, Carolina; Frankos, Marie; Tan, Ciara Natasha
IRB No: SMARTIRB 201801001
Protocol Abbrev: COMPPARE
Principal Investigator: Akash Nanda, MD, PhD
Age Group: Adult
Secondary Protocol No: AG12066
Treatment: Device: Standard of Care IMRT (Photon) Device: Standard of Care Proton Therapy Device: Proton Arm 1: Standard Proton Therapy Device: Proton Arm 2: Hypofractionated Proton Therapy
Therapies Involved: Radiation
ClinicalTrials.gov ID: NCT03561220
To determine if prostate cancer patients treated with
proton therapy as compared to IMRT experience improved QOL (validated EPIC instrument measuring bowel, urinary, and sexual QOL).
• Candidate for definitive prostate radiotherapy (either IMRT or proton).
• Patients to be treated with IMRT should have all treatment planned with IMRT; patients to be treated with protons should have all treatment planned with protons (including pelvic nodes if treated).
• Men diagnosed with adenocarcinoma of the prostate who have not received previous treatment with the exception of short-term (≤6 months) ADT according to NCCN guidelines (Appendix 6).
• Localized prostate cancer, as confirmed by staging (Appendices 1 and 2) with PSA, biopsy, Gleason score, DRE, and clinical stage.
• Nuclear medicine bone imaging is required for confirmation of the absence of overt metastatic disease in bones if any high-risk criteria are identified [clinical stage T3A; or ≤4 cores of Gleason score 8 (NCCN grade group 4) or 4+5; or PSA ≥20 ng/mL].
• Diagnosed with NCCN Risk Groups 1-4 low-risk; intermediate-risk; or high-risk disease that is characterized by only one of the following criteria: clinical stage T3A; or ≤4 cores of Gleason score 8 (NCCN grade group 4) or 4+5; or PSA ≥20 ng/mL.
• 30-80 years of age at the time of consent with a life expectancy of ≥10 years.
• ECOG/Zubrod Performance Status 0 - 2.