title: 3-D Conformal radiotherapy of localized prostate cancer within an Austrian-German multicenter trial: a prospective study of patients' acceptance of the rectal balloon during treatment.
abstract: OBJECTIVE
  Patients with localized prostate cancer are treated with 3D radiotherapy using a rectal balloon catheter for internal immobilization of the prostate, thereby reducing the radiation dose to the dorsal rectal wall. The purpose of the study was to investigate clinical feasibility and the influence of acute rectal side effects and pre-existing hemorrhoids on patients' acceptance of the rectal balloon catheter.
  
  
  METHODS
  442 patients who underwent primary radiation therapy for localized prostate cancer were included in this prospective Austrian-German multicenter trial. The total radiation dose was either 70 Gy or 74 Gy. Acute rectal side effects were documented using the EORTC/RTOG grading score (European Organisation for Research and Treatment of Cancer/Radiation Therapy 225 Oncology Group) at weeks 2, 4 and 7 of radiation treatment. Within the same time intervals patients were interviewed about their tolerance of the rectal balloon catheter, evaluating five categories of acceptance (1 = no major complaints, 2 = pain at/during application, 3 = signs of blood at the balloon catheter after application but without any pain, 4 = signs of blood at the balloon catheter after application and pain, 5 = balloon application had to be stopped). Voluntary rectoscopy prior to radiotherapy was performed in 310 patients.
  
  
  RESULTS
  429/442 patients (97 %) were treated with the balloon catheter. No major complaints were reported in 79 % of the patients and no acute rectal side effects were seen in 52 % of the patients. Grade 1 side effects were seen in 31 % patients, Grade 2 in 17 % and Grade 3 in 0.5 %. Balloon use had to be stopped in only 4 % of the patients. There was significant correlation between balloon discomfort and rectal side effects (p < 0.01). The presence of hemorrhoids in 36 % patients prior to irradiation had no influence on balloon tolerance.
  
  
  CONCLUSIONS
  The rectal balloon can be used in 3D radiotherapy of localized prostate cancer with a high degree of acceptance by the patients. Use of the balloon is safe within daily clinical treatment. Patients reporting acute rectal side effects experienced significantly more balloon discomfort, but the presence of hemorrhoids was not found to influence acceptance of the balloon.
authors.affiliation: Department of Radiotherapy and Radiobiology, Vienna General Hospital, University of Vienna Medical School, Vienna, Austria. Gregor.Goldner@akhwien.at
authors.forename: Gregor
authors.initials: G
authors.lastname: Goldner
authors.forename: Hans
authors.initials: H
authors.lastname: Geinitz
authors.forename: Stefan
authors.initials: S
authors.lastname: Wachter
authors.forename: Gerd
authors.initials: G
authors.lastname: Becker
authors.forename: Frank
authors.initials: F
authors.lastname: Zimmermann
authors.forename: Natascha
authors.initials: N
authors.lastname: Wachter-Gerstner
authors.forename: Stefan
authors.initials: S
authors.lastname: Glocker
authors.forename: Regina
authors.initials: R
authors.lastname: Pötzi
authors.forename: Andre
authors.initials: A
authors.lastname: Wambersie
authors.forename: Michael
authors.initials: M
authors.lastname: Bamberg
authors.forename: Michael
authors.initials: M
authors.lastname: Molls
authors.forename: Horst
authors.initials: H
authors.lastname: Feldmann
authors.forename: Richard
authors.initials: R
authors.lastname: Pötter
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001294:Attitude to Health; D001317:Austria / Q000453:epidemiology; D002404:Catheterization / Q000295:instrumentation / Q000379:methods / Q000706:statistics & numerical data*; D015897:Comorbidity; D003258:Consumer Behavior / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000706:statistics & numerical data*; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000453:epidemiology* / Q000532:radiotherapy*; D020266:Radiotherapy, Conformal / Q000295:instrumentation / Q000706:statistics & numerical data*; D012002:Rectal Diseases / Q000453:epidemiology; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D016896:Treatment Outcome