title: Early results of LH-RH agonist treatment with or without chlormadinone acetate for hormone therapy of naive localized or locally advanced prostate cancer: a prospective and randomized study. The Prostate Cancer Study Group.
abstract: BACKGROUND
  The majority of patients with localized and some cases of locally advanced prostate cancer undergo radical prostatectomy. However, radical prostatectomy cannot always be selected for those patients. In this situation, primary hormone therapy is an alternative treatment option. We have designed a prospective randomized study of the effects of primary hormone therapy for such patients.
  
  
  METHODS
  A total of 151 patients with T1b, T1c, T2a, T2b or T3a prostate cancer who were not scheduled for radical prostatectomy were enrolled into this study. Patients were randomly allocated into two groups; Group I received luteinizing hormone-releasing hormone (LH-RH) agonist monotherapy (leuprorelin acetate depot, 3.75 mg monthly) and Group II received LH-RH agonist in combination with chlormadinone acetate (100 mg/day). Effects on serum prostate-specific antigen level, progression-free survival and survival were observed for 2 years.
  
  
  RESULTS
  The reasons why radical prostatectomy was not scheduled were poor risk for surgery (38%), patient's wish (32%) and physician's recommendation (30%). After 12 weeks of treatment, 49% of the patients in both groups showed a complete response (CR). Of the patients showing a partial response (PR) after 12 weeks of treatment, 25% in Group I and 52% in Group II improved to CR 1 year later (p<0.05). Group II showed a longer progression-free survival (p <0.05). Progression-free survival rates were 62% (Group I) and 91% (Group II) in T2b patients and 43% (Group I) and 73% (Group II) in T3 patients. Only one patient in each group died from prostate cancer.
  
  
  CONCLUSIONS
  Early primary hormone therapy is a reasonable treatment option for localized or locally advanced prostate cancer patients if radical prostatectomy was not scheduled. Chlormadinone acetate showed an additive effect with LH-RH agonist, at least in 2 years' observation.
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: N
authors.initials: N
authors.lastname: Moriyama
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; D000726:Androgen Antagonists / Q000008:administration & dosage; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002715:Chlormadinone Acetate / Q000008:administration & dosage; D018572:Disease-Free Survival; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage*; D008297:Male; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D002715:Chlormadinone Acetate; D007987:Gonadotropin-Releasing Hormone; D016729:Leuprolide