title: Immediate or deferred androgen deprivation for patients with prostate cancer not suitable for local treatment with curative intent: European Organisation for Research and Treatment of Cancer (EORTC) Trial 30891.
abstract: OBJECTIVE
  This study (EORTC 30891) attempted to demonstrate equivalent overall survival in patients with localized prostate cancer not suitable for local curative treatment treated with immediate or deferred androgen ablation.
  
  
  METHODS
  We randomly assigned 985 patients with newly diagnosed prostate cancer T0-4 N0-2 M0 to receive androgen deprivation either immediately (n = 493) or on symptomatic disease progression or occurrence of serious complications (n = 492).
  
  
  RESULTS
  Baseline characteristics were well balanced in the two groups. Median age was 73 years (range, 52 to 81). At a median follow-up of 7.8 years, 541 of 985 patients had died, mostly of prostate cancer (n = 193) or cardiovascular disease (n = 185). The overall survival hazard ratio was 1.25 (95% CI, 1.05 to 1.48; noninferiority P > .1) favoring immediate treatment, seemingly due to fewer deaths of nonprostatic cancer causes (P = .06). The time from randomization to progression of hormone refractory disease did not differ significantly, nor did prostate-cancer specific survival. The median time to the start of deferred treatment after study entry was 7 years. In this group 126 patients (25.6%) died without ever needing treatment (44% of the deaths in this arm).
  
  
  CONCLUSIONS
  Immediate androgen deprivation resulted in a modest but statistically significant increase in overall survival but no significant difference in prostate cancer mortality or symptom-free survival. This must be weighed on an individual basis against the adverse effects of life-long androgen deprivation, which may be avoided in a substantial number of patients with a deferred treatment policy.
authors.affiliation: Department of Urology, University Hospital of Bern, Bern, Switzerland. urs.studer@insel.ch
authors.forename: Urs E
authors.initials: UE
authors.lastname: Studer
authors.forename: Peter
authors.initials: P
authors.lastname: Whelan
authors.forename: Walter
authors.initials: W
authors.lastname: Albrecht
authors.forename: Jacques
authors.initials: J
authors.lastname: Casselman
authors.forename: Theo
authors.initials: T
authors.lastname: de Reijke
authors.forename: Dieter
authors.initials: D
authors.lastname: Hauri
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Loidl
authors.forename: Santiago
authors.initials: S
authors.lastname: Isorna
authors.forename: Subramanian K
authors.initials: SK
authors.lastname: Sundaram
authors.forename: Muriel
authors.initials: M
authors.lastname: Debois
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists