TY - JOUR TI - Feasibility and radiation induced toxicity regarding the first application of transperineal implementation of biocompatible balloon for high dose radiotherapy in patients with prostate carcinoma AU - Kouloulias, V. AU - Kalogeropoulos, T. AU - Platoni, K. AU - Georgakopoulos, J. AU - Matsopoulos, G. AU - Chaldeopoulos, D. AU - Beli, I. AU - Pantelakos, P. AU - Asimakopoulos, C. AU - Kouvaris, J. AU - Kelekis, N. JO - Journal of Radiation Oncology PY - 2013 VL - 8 TODO - 1 SP - null PB - SN - null TODO - 10.1186/1748-717X-8-82 TODO - nonsteroid antiinflammatory agent; prostate specific antigen, aged; article; biocompatibility; cancer localization; cancer radiotherapy; clinical article; controlled study; dysuria; feasibility study; gastrointestinal toxicity; hematuria; human; male; nocturia; outcome assessment; penis erection; perineum; prostate carcinoma; questionnaire; radiation dose; radiation dose fractionation; radiation injury; rectum; rectum disease; retrospective study; sigmoidoscopy; tenesmus; transrectal ultrasonography; urinary urgency; urogenital tract disease; visual analog scale, Adenocarcinoma; Aged; Feasibility Studies; Humans; Male; Prostatic Neoplasms; Radiation Injuries; Radiotherapy, Conformal; Rectum TODO - Objective: To evaluate the feasibility of the transperineal implementation of biocompatible balloon (Prospace) and the acute toxicity of high dose 3DCRT in patients with localized low risk prostate cancer. Materials and methods: Between December 2011 and April 2012, fifteen patients were treated with external 3DCRT consisted of 76-78 Gy in 38-39 daily fractions (2.0 Gy/ fraction). Before 3DCRT, we placed the Prospace though the perineum by a minimally invasive procedure in the intermediate space between the rectum and the prostate. The primary study endpoint was the evaluation of acute toxicity according to the EORTC/RTOG radiation toxicity scale. Erectile function was evaluated with the IIEF-5 questionnaire. Rectosigmoidoscopy was performed at baseline, at the end of 3DCRT and 3 months thereafter in order to assess also the rectal toxicity according to Subjective-RectoSigmoid (S-RS) scale. The evaluation of pain related to Prospace implementation was done with the visual analogue score (VAS).Results: The acute toxicities were as follows: grade I GI toxicity in two patients and for GU toxicity, three patients with grade I of nocturia, four patients with grade I of frequency, two patients with grade I and two patients with grade II of dysouria. The mean score of rectal toxicity according to S-RS score was 1.8(±0.6). The mean VAS score related to Prospace was 1.4(±0.5). Erectile function was unchanged. The Prospace device was found stable in sequential CTs during irradiation.Conclusions: The implementation of PROSPACE was feasible, while the acute radiation toxicity was low and comparable with IMRT techniques. © 2013 Kouloulias et al.; licensee BioMed Central Ltd. ER -