Primary Outcome Measures:
- Number of Participants with Adverse Events [ Time Frame: Within 10 days ] [ Designated as safety issue: Yes ]
Unable to tolerate 10% of treatments using proton radiotherapy. Unable to complete all treatments. Cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.
- Acute Toxicity [ Time Frame: Within 60 days of completion of radiotherapy ] [ Designated as safety issue: Yes ]
Any grade 2 or higher GI or GU toxicity, other than GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU. In the feasibility phase of this trial, the observation window for acute toxicty is extended to 60 days from completion of radiotherapy, as a feasibility precaution.
Secondary Outcome Measures:
- Late toxicity [ Time Frame: open-ended ] [ Designated as safety issue: Yes ]
Any grade 2 or higher GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU which occurs beyond 60 days from completion of radiotherapy. Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system.
- Biochemical/clinicalprogression-free survival [ Designated as safety issue: Yes ]
The time from start of radiotherapy to either documented increase in PSA or clinical progression of disease (based on CT, MRI, or bone scan), death due to any cause or last patient contact alive.
This study will be done in two phases, first, a feasibility study and then a registration study. In the first, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 30 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.