A retrospective study of late adverse events in proton beam therapy for prostate cancer.

The efficacy and safety of proton beam therapy (PBT) were retrospectively evaluated in 111 consecutive patients with prostate cancer who underwent definitive PBT between 2008 and 2012. Following exclusion of 18 patients due to treatment suspension, loss to follow-up, and histology, the analysis included 93 patients with a median age of 68 years (range, 49-81 years). A total of 7, 32 and 54 prostate cancer patients were classified as low-, intermediate- and high-risk, respectively, as follows: High-risk, T≥3a or prostate-specific antigen (PSA) ≥20 ng/ml or Gleason Score ≥8; low-risk, T ≤2b and PSA≤10 ng/ml and Gleason Score=6; intermediate-risk, all other combinations. The median initial prostate-specific antigen (PSA) level was 9.75 ng/ml (range, 1.4-100 ng/ml) and the median Gleason score was 7 (range, 6-10). Patients with low-risk disease received 74 GyE (relative biological effectiveness=1.1) in 37 fractions, and those at intermediate or higher risk received 78 GyE in 39 fractions. Complete androgen blockade (CAB) therapy was performed from 6 months prior to PBT for patients with intermediate- or high-risk disease. CAB was continued during PBT and then terminated at the end of PBT for intermediate-risk patients. Patients at high risk continued CAB for 3 years. No combination therapy was used for low-risk patients. All the patients were followed up for >2 years after PBT, and all but one were PSA failure-free. The Common Terminology Criteria for Adverse Events v.4.0 was used to evaluate late adverse events. One patient developed grade 3 non-infectious cystitis and hematuria. Grade 2 urinary frequency was observed in 1 patient, and grade 2 rectal bleeding occurred in 4 patients. Of the 4 patients with grade 2 rectal bleeding, 2 received anticoagulant therapy, but none had diabetes mellitus or another high-risk comorbidity. The median time to occurrence of an adverse event of grade ≥2 was 14 months (range, 3-41 months). Therefore, the present retrospective study revealed that PBT at 78 GyE/39 Fr was well-tolerated and achieved good tumor control in patients with prostate cancer.