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Is High-Dose Leuprorelin Acetate Effective and Safe in Asian Men with Prostate Cancer? An Open-Label, Non-Comparative, Multi-Center Clinical Trial

 Seung-Hwan Lee  ;  Hyun-Moo Lee  ;  Sae-Woong Kim  ;  Eun-Sik Lee  ;  Sung-Joon Hong  ;  Choung-Soo Kim  ;  Taek-Won Kang  ;  Byung-Ha Chung 
 YONSEI MEDICAL JOURNAL, Vol.55(2) : 310-315, 2014 
Journal Title
Issue Date
Aged ; Aged, 80 and over ; Antineoplastic Agents, Hormonal/administration & dosage* ; Antineoplastic Agents, Hormonal/adverse effects ; Antineoplastic Agents, Hormonal/therapeutic use ; Asian Continental Ancestry Group ; Drug Administration Schedule ; Hot Flashes/chemically induced ; Humans ; Leuprolide/administration & dosage* ; Leuprolide/adverse effects ; Leuprolide/therapeutic use ; Male ; Middle Aged ; Penis/drug effects ; Prostate-Specific Antigen/blood ; Prostatic Neoplasms/drug therapy* ; Testis/drug effects ; Testosterone/blood ; Treatment Outcome
Prostate cancer ; adverse events ; luteinizing hormone releasing hormone agonist
PURPOSE: Leuprorelin is a well known luteinizing hormone releasing hormone agonist. However, there are insufficient data on the efficacy and safety of high dose leuprorelin acetate, especially in Asian patients with prostate cancer. We aimed to investigate the safety and efficacy of leuprorelin acetate 22.5 mg administered at three-month intervals in patients with prostate cancer. MATERIALS AND METHODS: In an open, prospective clinical trial enrolling 47 patients, we aimed to assess the efficacy and safety of leuprorelin acetate 22.5 mg in treating patients with histologically confirmed prostate cancer. The primary objective of this study was to evaluate the efficacy of the leuprorelin acetate 22.5 mg in producing and maintaining castration levels of testosterone over a 6-month follow-up period and to determine its safety profile. RESULTS: All 42 patients achieved serum testosterone levels within the castration range by 4 weeks. A breakthrough response was observed in one of 36 patients by 8 weeks. However, this patient was medically castrated by 12 weeks. There were no significant prostate-specific antigen (PSA) or testosterone changes according to clinical stage or body mass index. Twenty adverse events (AEs) in 15 of 42 patients (35.7%) were observed during this study. The most common AEs were hot flushes (n=4, 20.0%) with mild intensity, pain (n=2, 10.0%), and infection (n=2, 10.0%). No patient withdrew from the study due to AEs. CONCLUSION: Leuprorelin acetate 22.5 mg was shown to be effective and safe in Asian patients with prostate cancer, even though sexual function decreased.
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1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
Lee, Seung Hwan(이승환) ORCID logo https://orcid.org/0000-0001-7358-8544
Chung, Byung Ha(정병하) ORCID logo https://orcid.org/0000-0001-9817-3660
Hong, Sung Joon(홍성준) ORCID logo https://orcid.org/0000-0001-9869-065X
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