title: Effect of androgen deprivation therapy on local symptoms and tumour progression in men with metastatic carcinoma of the prostate.
abstract: OBJECTIVE
  To evaluate and compare the effects of medical or surgical castration combined with either nilutamide (Anandron) or placebo on symptoms of local tumour progression in men with carcinoma of the prostate.
  
  
  METHODS
  The results from twin, randomised, prospective, placebo-controlled trials were analysed. 434 patients received nilutamide 300 mg/day for 1 month and 150 mg thereafter, and 434 received a matched placebo from either the day of orchidectomy or the first leuprolide injection. Before treatment, and at months 1, 3, 6 and every 6 months thereafter, urinary obstruction and tumour volume were evaluated. Data on adverse or intercurrent events affecting the urological system were documented.
  
  
  RESULTS
  Before treatment, urinary obstructive symptoms and tumour volume were similar in both treatment groups. After treatment, improvement in urinary obstructive symptoms accompanied a decrease in prostate volume. The majority of men in both treatment groups reported an improvement in obstructive voiding symptoms. However, total adverse events secondary to local symptoms were significantly less frequent in the nilutamide-treated patients (20%) compared with the placebo-treated patients (35%). Only a small percentage of men in both treatment groups had disabling local symptoms and only 2% experienced problems with incontinence.
  
  
  CONCLUSIONS
  Local symptoms from primary tumour growth are relatively common in patients with metastatic carcinoma of the prostate and are favourably influenced by hormonal therapy. In these trials, the problems resulting from local tumour progression were significantly fewer in the group treated with castration plus nilutamide compared with the group treated with castration plus placebo.
authors.affiliation: Department of Urologic Surgery, Vanderbilt University, Nashville, TN 37232-2765, USA. joseph.smith@mcmail.vanderbilt.edu
authors.forename: J A
authors.initials: JA
authors.lastname: Smith
authors.forename: R A
authors.initials: RA
authors.lastname: Janknegt
authors.forename: C C
authors.initials: CC
authors.lastname: Abbou
authors.forename: A
authors.initials: A
authors.lastname: de Gery
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D002369:Castration; D006801:Humans; D006869:Hydronephrosis / Q000517:prevention & control; D007093:Imidazoles / Q000627:therapeutic use*; D048289:Imidazolidines; D016729:Leuprolide / Q000627:therapeutic use; D008297:Male; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D014555:Urination Disorders / Q000517:prevention & control
chemical_list: D000726:Androgen Antagonists; D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D007093:Imidazoles; D048289:Imidazolidines; C021277:nilutamide; D016729:Leuprolide