Rectal Toxicity After Extremely Hypofractionated Radiotherapy Using a Non-Isocentric Robotic Radiosurgery System for Early Stage Prostate Cancer.

Background: The aim of the study was to evaluate toxicity after extremely hypofractionated radiotherapy (EHF-RT) using a non-isocentric robotic radiosurgery system for early stage prostate cancer.

Methods: Eligibility criteria of this feasibility study were 50 - 84 years old, and low-risk to intermediate-risk disease. The prescribed dose to the iso-dose line of 95% of planning target volume was 35 Gy in five fractions over 2 weeks. The primary endpoint was the incidence of ≥ grade 2 acute toxicity which indicated symptoms requiring medications.

Results: We enrolled 20 patients from December 2012 to August 2014, and the median follow-up time was 30 months (range: 18 - 36). Sixteen patients had a short overall treatment time (OTT) of EHF-RT (9 - 10 days), and four patients had a long OTT (11 - 12 days) because of national holidays and patient's preference. The incidences of ≥ grade 2 acute toxicity in all sites, that in the rectum, and that in the genitourinary system, were 30%, 20%, and 10%, respectively. No patient developed severe acute toxicity (≥ grade 3). Among 16 patients with a short OTT of EHF-RT, four patients developed grade 2 acute rectal toxicity. Rectum-V (rectal volume receiving ≥ 28 Gy) of 3.8 mL or higher had a tendency to increase grade 2 acute rectal toxicity (P = 0.058). One patient developed grade 3 late rectal toxicity and no patient developed severe late genitourinary toxicity.

Conclusion: The incidences of ≥ grade 2 acute toxicity in all sites and that in the rectum after EHF-RT of 35 Gy in five fractions were 30% and 20%, respectively. High rectum-V was associated with grade 2 acute rectal toxicity after EHF-RT for early prostate cancer.