title: Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233).
abstract: BACKGROUND
  No studies to date have assessed the efficacy/tolerability of degarelix in the relief of lower urinary tract symptoms (LUTS) secondary to prostate cancer (PrCa).
  
  
  METHODS
  Patients were randomised to degarelix 240/80 mg or goserelin 3.6 mg + bicalutamide flare protection (G+B); both treatments were administered for 3 months. The primary endpoint was change in International Prostate Symptom Score (IPSS) at week 12 compared with baseline.
  
  
  RESULTS
  This study was stopped early due to recruitment difficulties. 40 patients received treatment (degarelix n = 27; G+B n = 13); most had locally advanced disease and were highly symptomatic. Degarelix was non-inferior to G+B in reducing IPSS at week 12 in the full analysis set (p = 0.20); the significantly larger IPSS reduction in the per-protocol analysis (p = 0.04) was suggestive of superior reductions with degarelix. Significantly more degarelix patients had improved quality of life (IPSS question) at week 12 (85 vs. 46%; p = 0.01). Mean prostate size reductions at week 12 were 42 versus 25% for patients receiving degarelix versus G+B, respectively (p = 0.04; post hoc analysis). Most adverse events were mild/moderate; more degarelix patients experienced injection site reactions whereas more G+B patients had urinary tract infections/cystitis.
  
  
  CONCLUSIONS
  In 40 men with predominantly locally advanced PrCa and highly symptomatic LUTS, degarelix was at least non-inferior to G+B in reducing IPSS at week 12.
authors.affiliation: Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.
authors.forename: John
authors.initials: J
authors.lastname: Anderson
authors.forename: Ghandi
authors.initials: G
authors.lastname: Al-Ali
authors.forename: Manfred
authors.initials: M
authors.lastname: Wirth
authors.forename: Joan Benejam
authors.initials: JB
authors.lastname: Gual
authors.forename: Francisco
authors.initials: F
authors.lastname: Gomez Veiga
authors.forename: Enrico
authors.initials: E
authors.lastname: Colli
authors.forename: Egbert
authors.initials: E
authors.lastname: van der Meulen
authors.forename: Bo-Eric
authors.initials: BE
authors.lastname: Persson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000813:Anilides / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D057239:Early Termination of Clinical Trials; D005060:Europe; D017273:Goserelin / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000150:complications*; D018401:Sample Size; D013997:Time Factors; D014105:Tosyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D009570:Nitriles; D009842:Oligopeptides; D014105:Tosyl Compounds; C431566:acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; D017273:Goserelin; C053541:bicalutamide