title: Quality of life, morbidity, and mortality results of a prospective phase II study of intermittent androgen suppression for men with evidence of prostate-specific antigen relapse after radiation therapy for locally advanced prostate cancer.
abstract: BACKGROUND
  Observations of quality of life (QOL), morbidity, and mortality were obtained from the results of a prospective phase II study of intermittent androgen suppression for recurrent prostate cancer after radiation therapy.
  
  
  METHODS
  Patients with histologically confirmed adenocarcinoma of the prostate and a rising serum prostate-specific antigen level after external-beam radiation of the prostate were treated intermittently with a 36-week course of cyproterone and leuprolide. At predetermined intervals, QOL was assessed using the Southwest Oncology Group 9346 QOL and the American Urological Association symptom score questionnaires. Progression-free and overall survival rates were estimated using the Kaplan-Meier method. Parameters related to progression were explored with univariate and multivariate analyses.
  
  
  RESULTS
  The incidence of adverse events was higher when patients were on treatment. Fatigue, dyspnea, and hematuria were the most common symptoms and signs recorded (50.5%, 24.8%, and 17.4%, respectively). Less frequent were myocardial infarction (7.3%), cerebrovascular accident (6.4%), and deep vein thrombosis (5.5%). Quality of life improved when off treatment, as indicated by a shift toward baseline levels in the scales depicting physical and work functions, hot flashes, impotence, sexual performance, urgency, and nocturia. Biochemical recurrence-free survival at 5 years was 70%, with a median > 6 years. The overall 5-year survival was 80%, similar to that of an age-matched population of normal men.
  
  
  CONCLUSIONS
  Intermittent androgen suppression is a potentially useful treatment for locally recurrent prostate cancer after radiation therapy with QOL benefits in the off-treatment interval and no apparent deleterious effects on short- to medium-term survival.
authors.affiliation: The Prostate Centre at Vancouver General Hospital, Department of Urologic Sciences, University of British Columbia, Canada. nbeinc@telus.net
authors.forename: Nicholas
authors.initials: N
authors.lastname: Bruchovsky
authors.forename: Laurence
authors.initials: L
authors.lastname: Klotz
authors.forename: Juanita
authors.initials: J
authors.lastname: Crook
authors.forename: Norman
authors.initials: N
authors.lastname: Phillips
authors.forename: Jonas
authors.initials: J
authors.lastname: Abersbach
authors.forename: S Larry
authors.initials: SL
authors.lastname: Goldenberg
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy; D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009017:Morbidity; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood* / Q000187:drug effects; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality* / Q000532:radiotherapy; D011788:Quality of Life; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D017430:Prostate-Specific Antigen