title: A prospective and randomized study of primary hormonal therapy for patients with localized or locally advanced prostate cancer unsuitable for radical prostatectomy: results of the 5-year follow-up.
abstract: OBJECTIVE
  To evaluate the effect of primary hormonal therapy for patients with localized and locally advanced prostate cancer.
  
  
  METHODS
  Patients with stage T1b-T3 prostate cancer who were not scheduled for radical prostatectomy were allocated into two groups: group 1 (73 men) received luteinizing hormone-releasing hormone (LHRH) agonist monotherapy and group 2 (78 men) received LHRH agonist and chlormadinone acetate. Patients were followed using serum prostate specific antigen levels, prostate size and the detection of distant metastasis for 5 years.
  
  
  RESULTS
  The median (range) follow-up was 78 (63-87) months. The 5-year progression-free survival rate was significantly higher in group 2 (68%) than in group 1 (47%). However, the overall and cause-specific survival rate at 5 years were similar in both groups, at 72% and 93% in group 1, and 64% and 89% in group 2, respectively.
  
  
  CONCLUSIONS
  The overall survival rates of the both groups were no different from that of the normal Japanese population of the same age group. Although this study did not include an untreated group, i.e. watchful waiting, these results might indicate the usefulness of primary hormonal therapy in controlling localized and locally advanced prostate cancer. The 5-year observation period is still short and the study is continuing to determine the 10-year survival.
authors.affiliation: Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan. akazah@md.tsukuba.ac.jp
authors.forename: H
authors.initials: H
authors.lastname: Akaza
authors.forename: Y
authors.initials: Y
authors.lastname: Homma
authors.forename: K
authors.initials: K
authors.lastname: Okada
authors.forename: M
authors.initials: M
authors.lastname: Yokoyama
authors.forename: M
authors.initials: M
authors.lastname: Usami
authors.forename: Y
authors.initials: Y
authors.lastname: Hirao
authors.forename: T
authors.initials: T
authors.lastname: Tsushima
authors.forename: Y
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Y
authors.initials: Y
authors.lastname: Aso
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D002715:Chlormadinone Acetate / Q000627:therapeutic use*; D005500:Follow-Up Studies; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D002715:Chlormadinone Acetate; D007987:Gonadotropin-Releasing Hormone; D017430:Prostate-Specific Antigen