title: Phase II trial of hypofractionated image-guided intensity-modulated radiotherapy for localized prostate adenocarcinoma.
abstract: OBJECTIVE
  To assess in a prospective trial the feasibility and late toxicity of hypofractionated radiotherapy (RT) for prostate cancer.
  
  
  METHODS
  Eligible patients had clinical stage T1c-2cNXM0 disease. They received 60 Gy in 20 fractions over 4 weeks with intensity-modulated radiotherapy including daily on-line image guidance with intraprostatic fiducial markers.
  
  
  RESULTS
  Between June 2001 and March 2004, 92 patients were treated with hypofractionated RT. The cohort had a median prostate-specific antigen value of 7.06 ng/mL. The majority had Gleason grade 5-6 (38%) or 7 (59%) disease, and 82 patients had T1c-T2a clinical staging. Overall, 29 patients had low-risk, 56 intermediate-risk, and 7 high-risk disease. Severe acute toxicity (Grade 3-4) was rare, occurring in only 1 patient. Median follow-up was 38 months. According to the Phoenix definition for biochemical failure, the rate of biochemical control at 14 months was 97%. According to the previous American Society for Therapeutic Radiology and Oncology definition, biochemical control at 3 years was 76%. The incidence of late toxicity was low, with no severe (Grade > or =3) toxicity at the most recent assessment.
  
  
  CONCLUSIONS
  Hypofractionated RT using 60 Gy in 20 fractions over 4 weeks with image guidance is feasible and is associated with low rates of late bladder and rectal toxicity. At early follow-up, biochemical outcome is comparable to that reported for conventionally fractionated controls. The findings are being tested in an ongoing, multicenter, Phase III trial.
authors.affiliation: Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, ON, Canada.
authors.forename: Jarad M
authors.initials: JM
authors.lastname: Martin
authors.forename: Tara
authors.initials: T
authors.lastname: Rosewall
authors.forename: Andrew
authors.initials: A
authors.lastname: Bayley
authors.forename: Robert
authors.initials: R
authors.lastname: Bristow
authors.forename: Peter
authors.initials: P
authors.lastname: Chung
authors.forename: Juanita
authors.initials: J
authors.lastname: Crook
authors.forename: Mary
authors.initials: M
authors.lastname: Gospodarowicz
authors.forename: Michael
authors.initials: M
authors.lastname: McLean
authors.forename: Cynthia
authors.initials: C
authors.lastname: Ménard
authors.forename: Michael
authors.initials: M
authors.lastname: Milosevic
authors.forename: Padraig
authors.initials: P
authors.lastname: Warde
authors.forename: Charles
authors.initials: C
authors.lastname: Catton
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000473:pathology / Q000532:radiotherapy* / Q000556:secondary; D000368:Aged; D001706:Biopsy; D019583:Dose Fractionation, Radiation; D005240:Feasibility Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology / Q000532:radiotherapy*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*; D016879:Salvage Therapy / Q000379:methods
chemical_list: D017430:Prostate-Specific Antigen