About this trial
The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.
Eligibility criteria
Qualifiers
Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
Maximum PSA value of 20 ng/ml.
Disqualifiers
Evidence of distant metastasis (M1).
Prior systemic chemotherapy for any reason.
Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
Trial design
Treatments tested in this trial
- IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
- Proton (prostate bed) to 70.2 CGE
- IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
- Proton to 66.6 CGE
Treatment groups
Sponsors and collaborators
Proton Collaborative Group
Lead sponsor
University of Florida Health
Collaborator