title: Ten-year follow-up of neoadjuvant therapy with goserelin acetate and flutamide before radical prostatectomy for clinical T3 and T4 prostate cancer: update on Southwest Oncology Group Study 9109.
abstract: OBJECTIVE
  To update the results with 10-year data of a phase II prospective trial of neoadjuvant hormonal therapy with goserelin acetate and flutamide followed by radical prostatectomy for locally advanced prostate cancer (SWOG 9109). The optimal management for clinical stage T3 and T4 N0,M0 prostate cancer is uncertain.
  
  
  METHODS
  Sixty-two patients with clinical stage T3 and T4 N0,M0 prostate cancer were enrolled. Cases were classified by stage T3 vs T4 and by volume of disease (bulky >4 cm and nonbulky ≤ 4 cm).
  
  
  RESULTS
  Fifty-five of 61 eligible patients completed the trial with radical prostatectomy after neoadjuvant androgen deprivation therapy (ADT). The median preoperative prostate-specific antigen value was 19.8 ng/mL, and 67% of patients had a Gleason score of ≥ 7. Among 41 patients last known to be alive, median follow-up is 10.6 years (range 5.1-12.6). In all, 38 patients have had disease progression (30/55, 55%) or died without progression (8/55, 15%) for a 10-year progression-free survival (PFS) estimate of 40% (95% CI 27-53). Median PFS was 7.5 years, and median survival has not been reached. The 10-year overall survival (OS) estimate is 68% (95% CI 56-80).
  
  
  CONCLUSIONS
  In this small, prospective phase II study, neoadjuvant hormonal therapy with goserelin acetate and flutamide followed by radical prostatectomy achieves long-term PFS and OS comparable with alternative treatments. This approach is feasible and may be an alternative to a strategy of combined radiation and ADT.
authors.affiliation: Department of Urology, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. berglur@ccf.org
authors.forename: Ryan K
authors.initials: RK
authors.lastname: Berglund
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Tangen
authors.forename: Isaac J
authors.initials: IJ
authors.lastname: Powell
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Lowe
authors.forename: Gabriel P
authors.initials: GP
authors.lastname: Haas
authors.forename: Peter R
authors.initials: PR
authors.lastname: Carroll
authors.forename: Edith D
authors.initials: ED
authors.lastname: Canby-Hagino
authors.forename: Ralph
authors.initials: R
authors.lastname: deVere White
authors.forename: George P
authors.initials: GP
authors.lastname: Hemstreet
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
authors.forename: Ian M
authors.initials: IM
authors.lastname: Thompson
authors.forename: Eric A
authors.initials: EA
authors.lastname: Klein
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005485:Flutamide / Q000008:administration & dosage*; D005500:Follow-Up Studies; D017273:Goserelin / Q000008:administration & dosage*; D006801:Humans; D055104:Infusions, Subcutaneous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D017273:Goserelin; D005485:Flutamide