title: High dose rate brachytherapy in combination with external beam radiotherapy in the radical treatment of prostate cancer: initial results of a randomised phase three trial.
abstract: OBJECTIVE
  A randomised phase III trial has compared external beam radiotherapy alone with a dose escalated schedule using high dose rate brachytherapy. Patients with histologically confirmed prostate cancer, no evidence of metastases, a PSA <50, no previous TURP and fit for general anaesthetic were included.
  
  
  METHODS
  Patients were randomised to receive either standard radiotherapy 55 Gy in 20 fractions treating Monday to Friday over 4 weeks or a combined schedule comprising external beam treatment delivering 35.75 Gy in 13 fractions treating daily Monday to Friday over 2.5 weeks followed by a temporary high dose rate afterloading implant delivering 17 Gy in two fractions over 24h.
  
  
  RESULTS
  A total of 220 patients were randomised, balanced for important prognostic parameters including tumour stage, presenting PSA, Gleason score and use of adjuvant anti-androgens. With a median follow up of 30 months (range 3-91) a significant improvement in actuarial biochemical relapse-free survival is seen in favour of the combined brachytherapy schedule (p=0.03). A lower incidence of acute rectal discharge was seen in the brachytherapy group (p=0.025) and other acute and late toxicities were equivalent. Patients randomised to brachytherapy had a significantly better FACT-P score at 12 weeks (p=0.02).
  
  
  CONCLUSIONS
  The use of high dose rate brachytherapy in combination with external beam radiotherapy resulted in an improved biochemical relapse-free survival compared to external beam radiotherapy alone with less acute rectal toxicity and improved quality of life in this randomised trial.
authors.affiliation: Mount Vernon Cancer Centre, Northwood, Middlesex, UK. peterhoskin@nhs.net
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Hoskin
authors.forename: Kate
authors.initials: K
authors.lastname: Motohashi
authors.forename: Peter
authors.initials: P
authors.lastname: Bownes
authors.forename: Linda
authors.initials: L
authors.lastname: Bryant
authors.forename: Peter
authors.initials: P
authors.lastname: Ostler
mesh_terms: D000368:Aged; D001918:Brachytherapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011471:Prostatic Neoplasms / Q000401:mortality / Q000532:radiotherapy*