title: Radical prostatectomy and adjuvant endocrine therapy for prostate cancer with or without preoperative androgen deprivation: Five-year results.
abstract: BACKGROUND
  The effects of preoperative androgen deprivation on the outcomes of prostate cancer patients who received radical prostatectomy and subsequent adjuvant endocrine therapy have not yet been fully evaluated.
  
  
  METHODS
  Patients with stage A(2), B or C prostate cancers were randomized to one of two groups: group I (n = 90), who received androgen deprivation (leuprolide and chlormadinone acetate) for 3 months followed by radical prostatectomy and subsequent adjuvant endocrine therapy (leuprolide alone), and group II (n = 86), who underwent the surgery followed by 3-month androgen deprivation (leuprolide and chlormadinone acetate) and subsequent adjuvant endocrine therapy (leuprolide alone). The effects of preoperative androgen deprivation on survival, clinical relapse (serum prostate specific antigen, PSA, above the normal level, local recurrence, or distant metastases), and PSA relapse (PSA above the detectable level) were evaluated at 5 years or later after treatment.
  
  
  RESULTS
  There were no significant differences in overall, cause-specific, clinical relapse-free, or PSA relapse-free survival rates between the two groups. In a subanalysis, no prostate cancer deaths or clinical relapses were noted in 29 patients with organ-confined disease (OCD: negativity of capsular invasion, seminal vesicle invasion, surgical margins or nodal involvement). The odds ratio for OCD depending on group assignment was 2.44 (95% confidence interval, CI 1.04-5.72), for group I, demonstrating a higher probability of having OCD. This ratio was increased to 4.00 (95% CI 1.06-15.16) if the analysis was conducted in a subpopulation with prostate specific antigen levels less than 35.6 ng/mL and with clinical stage B or C cancers.
  
  
  CONCLUSIONS
  Preoperative androgen deprivation has no demonstrable benefit in 5-year outcomes for patients undergoing radical prostatectomy and adjuvant endocrine therapy. However, it did increase the probability of OCD, which was associated with no clinical relapse during the follow-up. A longer observation is needed to clarify the exact extent of the benefits in terms of survival.
authors.affiliation: Department of Urology, University of Tokyo, Tokyo, Japan. homma-uro@umin.ac.jp
authors.forename: Yukio
authors.initials: Y
authors.lastname: Homma
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
authors.forename: Kiyoki
authors.initials: K
authors.lastname: Okada
authors.forename: Masao
authors.initials: M
authors.lastname: Yokoyama
authors.forename: Nobuo
authors.initials: N
authors.lastname: Moriyama
authors.forename: Michiyuki
authors.initials: M
authors.lastname: Usami
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Hirao
authors.forename: Tomoyasu
authors.initials: T
authors.lastname: Tsushima
authors.forename: Atsuhiko
authors.initials: A
authors.lastname: Sakamoto
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Aso
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002715:Chlormadinone Acetate / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D006801:Humans; D016729:Leuprolide / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011300:Preoperative Care; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D002715:Chlormadinone Acetate; D017430:Prostate-Specific Antigen; D016729:Leuprolide