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).
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
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
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
Prostate international 2015 Feb 12 [Epub]
Dalsan You, Byung Ha Chung, Sang Eun Lee, Choung-Soo Kim
Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea , Department of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea , Department of Urology, Seoul National University Bundang Hospital, Seongnam, South Korea , Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea