Abstract
Purpose: To report 5-year outcomes of a prospective trial of image-guided accelerated hypofractionated proton therapy (AHPT) for prostate cancer.Patients and methods: 215 prostate cancer patients accrued to a prospective institutional review board-approved trial of 70Gy(RBE) in 28 fractions for low-risk disease (n = 120) and 72.5Gy(RBE) in 29 fractions for intermediate-risk disease (n = 95). This trial excluded patients with prostate volumes of ≥60 cm3 or International Prostate Symptom Scores (IPSS) of ≥15, patients on anticoagulants or alpha-blockers, and patients in whom dose-constraint goals for organs at risk (OAR) could not be met. Toxicities were graded prospectively according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. This trial can be found on ClinicalTrials.gov (NCT00693238).Results: Median follow-up was 5.2 years. Five-year rates of freedom from biochemical and clinical disease progression were 95.9%, 98.3%, and 92.7% in the overall group and the low- and intermediate-risk subsets, respectively. Actuarial 5-year rates of late radiation-related CTCAE v3.0 grade 3 or higher gastrointestinal and urologic toxicities were 0.5% and 1.7%, respectively. Median IPSS before treatment and at 4+ years after treatment were 6 and 5 for low-risk patients and 4 and 6 for intermediate-risk patients.Conclusions: Image-guided AHPT 5-year outcomes show high efficacy and minimal physician-assessed toxicity in selected patients. These results are comparable to the 5-year results of our prospective trials of standard fractionated proton therapy for patients with low-risk and intermediate-risk prostate cancer. Longer follow-up and a larger cohort are necessary to confirm these findings.
Highlights
Interest in accelerated hypofractionated photon radiation therapy in the treatment of prostate cancer has developed with the recent ability to create highly conformal photonbased radiation dose distributions, and several investigators have reported safety and efficacy with various hypofractionation schemes [1,2,3,4]
The purpose of this study is to report the 5-year outcomes of a prospective trial to determine the safety and efficacy of accelerated hypofractionated proton therapy (AHPT) in prostate cancer
From April 2008 through October 2011, 215 patients enrolled in an institutional review board-approved protocol, PR04, for low-risk (n 1⁄4 120) and intermediate-risk (n 1⁄4 95) prostate cancer designed to test the feasibility of an AHPT regimen
Summary
Interest in accelerated hypofractionated photon radiation therapy in the treatment of prostate cancer has developed with the recent ability to create highly conformal photonbased radiation dose distributions, and several investigators have reported safety and efficacy with various hypofractionation schemes [1,2,3,4]. Proton therapy provides more conformal radiation dose distributions than photon-based radiation therapy, but mature data on clinical outcomes with accelerated hypofractionated proton therapy (AHPT) are limited [5]. The purpose of this study is to report the 5-year outcomes of a prospective trial to determine the safety and efficacy of AHPT in prostate cancer
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