title: Using PSA to guide timing of androgen deprivation in patients with T0-4 N0-2 M0 prostate cancer not suitable for local curative treatment (EORTC 30891).
abstract: OBJECTIVE
  EORTC trial 30891 compared immediate versus deferred androgen-deprivation therapy (ADT) in T0-4 N0-2 M0 prostate cancer (PCa). Many patients randomly assigned to deferred ADT did not require ADT because they died before becoming symptomatic. The question arises whether serum prostate-specific antigen (PSA) levels may be used to decide when to initiate ADT in PCa not suitable for local curative treatment.
  
  
  METHODS
  PSA data at baseline, PSA doubling time (PSADT) in patients receiving no ADT, and time to PSA relapse (>2 ng/ml) in patients whose PSA declined to <2 ng/ml within the first year after immediate ADT were analyzed in 939 eligible patients randomly assigned to immediate (n=468) or deferred ADT (n=471).
  
  
  RESULTS
  In both arms, patients with a baseline PSA>50 ng/ml were at a>3.5-fold higher risk to die of PCa than patients with a baseline PSA<or=8 ng/ml. If baseline PSA was between 8 and 50 ng/ml, the risk of PCa death was approximately 7.5-fold higher in patients with PSADT<12 mo than in patients with PSADT>12 mo. Time to PSA relapse after response to immediate ADT correlated significantly with baseline PSA, suggesting that baseline PSA may also reflect disease aggressiveness.
  
  
  CONCLUSIONS
  Patients with a baseline PSA>50 ng/ml and/or a PSADT<12 mo were at increased risk to die from PCa and might have benefited from immediate ADT, whereas patients with a baseline PSA<50 ng/ml and a slow PSADT (>12 mo) were likely to die of causes unrelated to PCa, and thus could be spared the burden of immediate ADT.
authors.affiliation: Department of Urology, University Hospital of Bern, Switzerland. Urs.Studer@insel.ch
authors.forename: Urs E
authors.initials: UE
authors.lastname: Studer
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
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: Hartmut
authors.initials: H
authors.lastname: Knönagel
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
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging / Q000379:methods; D009919:Orchiectomy / Q000379:methods*; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000473:pathology / Q000628:therapy; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen