title: [8-month neoadjuvant hormonal therapy before radical prostatectomy for high-risk prostate cancer].
abstract: OBJECTIVE
  To evaluate the clinicopathological outcomes of 8 months of neoadjuvant hormonal therapy (NHT) prior to radical prostatectomy for high-risk prostate cancer.
  
  
  METHODS
  A multi-institutional prospective trial was performed between July 2000 and May 2003 involving high-risk prostate cancer patients without metastasis, including 21 who received 8 months of NHT before radical prostatectomy. High-risk group was defined as clinical stage > or =T2c and/or prostate-specific antigen (PSA) >20 ng/ml and/or Gleason score > or =8. PSA values were considered elevated (biochemical failure) if values of 0.1 ng/ml or greater were obtained.
  
  
  RESULTS
  Median of initial PSA levels before prostate biopsy was 27.6 ng/ml (8.5-80.7 ng/ml), and median of pre-operative PSA levels after NHT was 0.28 ng/ml (0.02-4.2 ng/ml). There were 5 patients (23.8%) with lower limit of PSA detection (less than 0.02 ng/ml) in 8 months after NHT. The clinical T stage was T1c in 9 patients (42.9%), T2a-b in 8 patients (38.1%), T2c in 3 patients (14.3%), and T3a in 1 patient (4.8%). The median follow-up was 25 months (range 4 to 37). There were 2 patients (9.5%) in pT0, 5 patients (23.8%) with positive surgical margin, 5 patients (23.8%) with extracapsular extension (ECE) and 3 patients (14.3%) with seminal vesicle involvement (SVI). Biochemical failure was occurred in 9 of 21 (42.9%) including of one pT0. Range of time to postoperative biochemical failure was 2 to 25 months (median 6 months) and most of biochemical failure was found within 12 months after surgery. Biochemical failure rate was significantly higher in patient with positive SVI (p = 0.0308) and higher in patients with pre-operative PSA levels of more than 0.1 ng/ml (p = 0.0836), positive ECE (p = 0.0545) and positive surgical margin (p = 0.0545).
  
  
  CONCLUSIONS
  Biochemical failure was frequent after this combined treatment, even in a pT0 case. Long-term follow-up of patients is needed to assess the impact of this therapy on mortality.
authors.affiliation: Department of Urology, Kitasato University, School of Medicine.
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Tabata
authors.forename: Takefumi
authors.initials: T
authors.lastname: Satoh
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Matsumoto
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Fujita
authors.forename: Akira
authors.initials: A
authors.lastname: Irie
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Iwamura
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yanagisawa
authors.forename: Daisuke
authors.initials: D
authors.lastname: Matsuda
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Muramoto
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Kadowaki
authors.forename: Kazuho
authors.initials: K
authors.lastname: Suyama
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Shoji
authors.forename: Hideshige
authors.initials: H
authors.lastname: Koh
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Kawakami
authors.forename: Isao
authors.initials: I
authors.lastname: Okayasu
authors.forename: Shin
authors.initials: S
authors.lastname: Egawa
authors.forename: Shiro
authors.initials: S
authors.lastname: Baba
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage*; D000813:Anilides / Q000008:administration & dosage; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D014408:Biomarkers, Tumor / Q000097:blood; D017024:Chemotherapy, Adjuvant; D017273:Goserelin / Q000008:administration & dosage; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009570:Nitriles; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000628:therapy*; D012306:Risk; D013997:Time Factors; D014105:Tosyl Compounds; D017211:Treatment Failure
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D018931:Antineoplastic Agents, Hormonal; D014408:Biomarkers, Tumor; D009570:Nitriles; D014105:Tosyl Compounds; D017273:Goserelin; C053541:bicalutamide; D017430:Prostate-Specific Antigen; D016729:Leuprolide