Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study
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 condu...
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doaj-098261caa95e4dbb962c3f4a729763002020-11-24T22:43:46ZengElsevierProstate International2287-88822015-03-0131222610.1016/j.prnil.2015.02.005Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III studyDalsan You0Byung Ha Chung1Sang Eun Lee2Choung-Soo Kim3Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South KoreaDepartment of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul, South KoreaDepartment of Urology, Seoul National University Bundang Hospital, Seongnam, South KoreaDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South KoreaPurpose: 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.http://www.sciencedirect.com/science/article/pii/S2287888215000069Androgen deprivation therapyDegarelixKoreanProstate cancerTestosterone |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Dalsan You Byung Ha Chung Sang Eun Lee Choung-Soo Kim |
spellingShingle |
Dalsan You Byung Ha Chung Sang Eun Lee Choung-Soo Kim Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study Prostate International Androgen deprivation therapy Degarelix Korean Prostate cancer Testosterone |
author_facet |
Dalsan You Byung Ha Chung Sang Eun Lee Choung-Soo Kim |
author_sort |
Dalsan You |
title |
Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study |
title_short |
Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study |
title_full |
Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study |
title_fullStr |
Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study |
title_full_unstemmed |
Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study |
title_sort |
efficacy and safety of degarelix in korean patients with prostate cancer requiring androgen deprivation therapy: open-label multicenter phase iii study |
publisher |
Elsevier |
series |
Prostate International |
issn |
2287-8882 |
publishDate |
2015-03-01 |
description |
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. |
topic |
Androgen deprivation therapy Degarelix Korean Prostate cancer Testosterone |
url |
http://www.sciencedirect.com/science/article/pii/S2287888215000069 |
work_keys_str_mv |
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