title: Degarelix Versus Goserelin Plus Bicalutamide in the Short-Term Relief of Lower Urinary Tract Symptoms in Prostate Cancer Patients: Results of a Pooled Analysis.
abstract: OBJECTIVE
  In patients with prostate cancer (PCa), prostate enlargement may give rise to lower urinary tract symptoms (LUTS); many patients suffer from moderate-to-severe symptoms. We compare the efficacy of degarelix and goserelin plus bicalutamide in improving LUTS in PCa patients.
  
  
  METHODS
  Data were pooled from three Phase 3, randomized clinical trials of once-monthly treatment for 12 weeks with degarelix (240/80 mg; n = 289) or goserelin (3.6 mg) plus bicalutamide (50 mg; n = 174) for initial flare protection. LUTS at weeks 4, 8, and 12 were compared to baseline. Clinically relevant LUTS relief was a ≥3-point International Prostate Symptom Score (IPSS) decrease. Adverse events were assessed throughout the trials.
  
  
  RESULTS
  Patients receiving degarelix had significantly greater decreases in IPSS vs. goserelin at week 12 (adjusted difference: -1.24; 95% CI -2.33 to -0.14, P = 0.03). Clinically relevant LUTS relief with degarelix was especially pronounced in patients with moderate-to-severe LUTS (baseline IPSS ≥13) (odds ratio; OR 2.31; 95% CI 1.19-4.47, P = 0.01) and advanced PCa (OR 2.36; 95% CI 1.10-5.04, P = 0.03). A twofold higher OR for early (week 4) LUTS relief was seen with degarelix vs. goserelin (OR 2.03; 95% CI 1.14-3.60, P = 0.02). No difference in total prostate volume or urinary tract infection-related adverse events (2%) was seen between treatment groups.
  
  
  CONCLUSIONS
  An early, significant and clinically more pronounced improvement of LUTS, especially in patients with moderate-to-severe LUTS or advanced PCa, was seen with degarelix vs. goserelin plus bicalutamide.
authors.affiliation: School of Medicine, Institute of Cancer and Genetics, Cardiff University, Cardiff, UK.
authors.forename: Malcolm
authors.initials: M
authors.lastname: Mason
authors.affiliation: School of Medicine, Institute of Cancer and Genetics, Cardiff University, Cardiff, UK.
authors.forename: Pierre
authors.initials: P
authors.lastname: Richaud
authors.affiliation: School of Medicine, Institute of Cancer and Genetics, Cardiff University, Cardiff, UK.
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Bosnyak
authors.affiliation: School of Medicine, Institute of Cancer and Genetics, Cardiff University, Cardiff, UK.
authors.forename: Anders
authors.initials: A
authors.lastname: Malmberg
authors.affiliation: School of Medicine, Institute of Cancer and Genetics, Cardiff University, Cardiff, UK.
authors.forename: Anders
authors.initials: A
authors.lastname: Neijber
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D000726:Androgen Antagonists / Q000008:administration & dosage*; D000813:Anilides / Q000008:administration & dosage*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D017273:Goserelin / Q000008:administration & dosage*; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D008297:Male; D009570:Nitriles / Q000008:administration & dosage*; D009842:Oligopeptides / Q000008:administration & dosage*; D009929:Organ Size; D011467:Prostate / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000150:complications / Q000188:drug therapy / Q000473:pathology; D013739:Testosterone / Q000378:metabolism; D014105:Tosyl Compounds / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D018931:Antineoplastic Agents, Hormonal; 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; D013739:Testosterone; C053541:bicalutamide; D017430:Prostate-Specific Antigen
keywords: bicalutamide; degarelix; goserelin; lower urinary tract symptoms