Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study

Dalsan You, Byung Ha Chung, Sang Eun Lee, Choung Soo Kim

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Abstract Purpose 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.

Original languageEnglish
Article number5
Pages (from-to)22-26
Number of pages5
JournalProstate International
Volume3
Issue number1
DOIs
Publication statusPublished - 2015 Mar 1

Bibliographical note

Funding Information:
This study was funded by Ferring Pharmaceuticals. Medical writing assistance (funded by Ferring Pharmaceuticals (Saint Prex, Switzerland)) was provided by Thomas Lavelle of Bioscript Medical (Macclesfield, Cheshire, United Kingdom).

All Science Journal Classification (ASJC) codes

  • Urology

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