title: Bicalutamide 150 mg maintains bone mineral density during monotherapy for localized or locally advanced prostate cancer.
abstract: OBJECTIVE
  We evaluated changes in bone mineral density (BMD), fat-free mass (FFM) and serum lipid levels during bicalutamide 150 mg monotherapy compared with medical castration for 2 years.
  
  
  METHODS
  A total of 103 men with localized or locally advanced prostate cancer (T1-T4, Nx, M0) for whom immediate androgen deprivation was indicated were enrolled in this prospective, multicenter, open-label, parallel group study. Patients were randomized to bicalutamide 150 mg once daily (51) or medical castration with a luteinizing hormone releasing hormone analogue (52) for 96 weeks. Primary end points were mean percent change from baseline in lumbar spine BMD, hip BMD and FFM at 96 weeks. Mean changes in lipid parameters with time were also evaluated.
  
  
  RESULTS
  BMD was maintained during bicalutamide 150 mg monotherapy (+2.42% for lumbar spine BMD and +1.13% for hip BMD at week 96), while castration was associated with a progressive loss in BMD (-5.40% and -4.39% at week 96, respectively, both p <0.0001 at week 96). There was no significant difference between bicalutamide 150 mg and castration in mean percent change from baseline in FFM (-1.56% and -3.86%, respectively, at week 96, p = 0.31), although there was a trend for greater progressive loss over time with castration. Mean changes in lipid parameters were small and similar in the 2 groups.
  
  
  CONCLUSIONS
  Bicalutamide 150 mg monotherapy may offer an important advantage compared to castration in terms of bone loss and body composition for patients who require long-term androgen deprivation for localized or locally advanced prostate cancer.
authors.affiliation: Urological Associates of Lancaster Ltd, Lancaster, Pennsylvania 17604-3200, USA. psieber610@aol.com
authors.forename: Paul R
authors.initials: PR
authors.lastname: Sieber
authors.forename: Danny L
authors.initials: DL
authors.lastname: Keiller
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Kahnoski
authors.forename: Jose
authors.initials: J
authors.lastname: Gallo
authors.forename: Scott
authors.initials: S
authors.lastname: McFadden
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000008:administration & dosage*; D000813:Anilides / Q000008:administration & dosage*; D015519:Bone Density / Q000187:drug effects*; D007987:Gonadotropin-Releasing Hormone / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D013997:Time Factors; D014105:Tosyl Compounds
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D008055:Lipids; D009570:Nitriles; D014105:Tosyl Compounds; D007987:Gonadotropin-Releasing Hormone; C053541:bicalutamide