title: PMH 9907: Long-term outcomes of a randomized phase 3 study of short-term bicalutamide hormone therapy and dose-escalated external-beam radiation therapy for localized prostate cancer.
abstract: BACKGROUND
  The role of hormone therapy (HT) with dose-escalated external-beam radiotherapy (DE-EBRT) in the treatment of intermediate-risk prostate cancer (IRPC) remains controversial. The authors report the long-term outcome of a phase 3 study of DE-EBRT with or without HT for patients with localized prostate cancer (LPC).
  
  
  METHODS
  From 1999 to 2006, 252 of an intended 338 patients with LPC were randomized to receive DE-EBRT with or without 5 months of neoadjuvant and concurrent bicalutamide 150 mg once daily. The study was closed early because of contemporary concerns surrounding bicalutamide. The primary outcome was biochemical failure (BF) incidence, and the secondary endpoints were overall survival (OS), local control (LC), and quality of life. The BF and OS rates were estimated using the cumulative incidence function and Kaplan-Meier methods and were compared using the Gray test and the log-rank test.
  
  
  RESULTS
  Eleven patients were excluded from analysis. Characteristics were well balanced in each treatment arm. Ninety-five percent of patients had IRPC. The prescribed dose increased from 75.6 grays (Gy) in 42 fractions to 78 Gy in 39 fractions over the period. At a median follow-up of 9.1 years, 98 BFs occurred, with no significant effect of HT versus no HT on the BF rate (40% vs 47%; P = .32), the OS rate (82% vs 86%; P = .37), the LC rate (52% vs 48 %; P = .32) or quality of life, in the patients who completed the questionnaires. Dose escalation to 75.6 Gy versus >75.6 Gy reduced the BF rate by 26% (P = .004).
  
  
  CONCLUSIONS
  For patients who predominantly have IRPC, the addition of HT to DE-EBRT did not significantly affect BF, OS, or LC. Bicalutamide appeared to be well tolerated. The conclusions from the study are limited by incomplete recruitment. Cancer 2016;122:2595-603. © 2016 American Cancer Society.
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.|Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: McPartlin
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.|Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
authors.forename: Rachel
authors.initials: R
authors.lastname: Glicksman
authors.affiliation: Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Melania
authors.initials: M
authors.lastname: Pintilie
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Debbie
authors.initials: D
authors.lastname: Tsuji
authors.affiliation: Department of Radiology, Radiation Oncology, and Nuclear Medicine, University Hospital Center of Montreal, Montreal, Quebec, Canada.
authors.forename: Gary
authors.initials: G
authors.lastname: Mok
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.|Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bayley
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.|Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Chung
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.|Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Bristow
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.|Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
authors.forename: Mary K
authors.initials: MK
authors.lastname: Gospodarowicz
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.|Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
authors.forename: Charles N
authors.initials: CN
authors.lastname: Catton
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.|Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Milosevic
authors.affiliation: Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.|Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
authors.forename: Padraig R
authors.initials: PR
authors.lastname: Warde
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000813:Anilides / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods; D003131:Combined Modality Therapy; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D011788:Quality of Life; D014105:Tosyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D000970:Antineoplastic Agents; D009570:Nitriles; D014105:Tosyl Compounds; C053541:bicalutamide
keywords: bicalutamide; dose escalated; intermediate risk; prostate; radiotherapy