Clinical effects of rectal retractor application in prostate cancer radiotherapy

Background: Radiation-induced rectal toxicities remain as a major risk during prostate radiotherapy. One approach to the reduction of rectal radiation dose is to physically increase the distance between the rectal wall and prostate. Therefore, the aim of this study was to evaluate whether the application of the rectal retractor (RR) can reduce rectal dose and toxicity in prostate cancer 3-dimensional conformal radiotherapy (3D-CRT). Methods: Overall, 36 patients with localized prostate cancer were randomized into the 2 groups, 18 patients with RR in-place and 18 without RR. All patients underwent planning computed tomography (CT). Patients were treated with 70 Gy in 35 fractions of 3D-CRT. In the RR group, RR was used during cone-down 20 treatment fractions. Acute and late gastrointestinal (GI) toxicities were assessed using EORTC/RTOG scoring system weekly during radiotherapy, 3, and 12 months after treatment. Device-related events were recorded according to CTCAE version 4.0. Patient characteristics, cancer differences, and dosimetric data for the RR and non-RR groups were compared using a Man-Whitney U test for continuous variables, and Fisher exact test for categorical data. The EORTC/RTOG scores for the 2 groups were compared using Fisher exact test. A P value <0.05 was considered statistically significant. Results: A RR significantly reduced mean dose (Dmean) to the rectum as well as rectal volume receiving 50% to 95% (V50-95%) of prescribed dose. The absolute reduction of rectal Dmean was 10.3 Gy. There was no statistically significant difference in acute GI toxicity between groups during treatment or at 3 months. At 12 months, 2 patients in the RR group and 9 in the control group experienced late grade ≥ 1 GI toxicity (p=0.027). No patients in the RR group reported late grade ≥ 2 GI toxicity, whereas 3 patients in the control group experienced late grade 2 GI toxicity. In the RR group, 6 patients reported grade 1 rectal discomfort and pain according to CTCAE version 4.0. Conclusion: The application of the RR showed a significant rectum sparing effect, resulting in substantially reducing late GI toxicity.