title: Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study.
abstract: OBJECTIVE
  To assess the noninferiority, efficacy, and safety of degarelix in achieving and maintaining testosterone at castrate levels (≤0.5 ng/mL) in Korean patients (CS42) versus non-Asian patients with prostate cancer (PCa).
  
  
  METHODS
  A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa. Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months. The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.
  
  
  RESULTS
  The estimated difference in the cumulative probabilities of testosterone ≤0.5 ng/mL from Day 28 to Day 196 between the trials was -2.3% (96.7% in CS42 vs. 99.0% in CS21). The lower limit of the 95% confidence interval was -5.5%, i.e., above the predefined noninferiority limit of -10% and thus noninferiority was established. Decreases in serum testosterone, prostate-specific antigen, and luteinizing hormone over time were similar in CS42 and CS21. There were no clinically significant differences in incidence of treatment-emergent adverse events (72% in CS42 vs. 70% in CS21) and changes in clinical chemistry and hematology parameters between the two trials. The most common adverse event was injection-site reaction.
  
  
  CONCLUSIONS
  Overall, degarelix was effective and well tolerated in Korean patients. Testosterone suppression was noninferior to that in non-Asian patients and safety findings were as would be expected for elderly men with PCa undergoing androgen deprivation therapy.
authors.affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors.forename: Dalsan
authors.initials: D
authors.lastname: You
authors.affiliation: Department of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
authors.forename: Byung Ha
authors.initials: BH
authors.lastname: Chung
authors.affiliation: Department of Urology, Seoul National University Bundang Hospital, Seongnam, South Korea.
authors.forename: Sang Eun
authors.initials: SE
authors.lastname: Lee
authors.affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors.forename: Choung-Soo
authors.initials: CS
authors.lastname: Kim
keywords: Androgen deprivation therapy; Degarelix; Korean; Prostate cancer; Testosterone