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전립선암 환자에서 Leuprolide Acetate Depot (루피어® 데포주 3.75mg)의 유효성과 안전성 평가를 위한 다기관 임상시험

Other Titles
 The Multi-center Clinical Trial of Leuprolide Acetate Depot(LphereⓡDepot inj 3.75mg) for Evaluation of Efficacy and Safety in Patients with Prostate Cancer 
 김형진  ;  유정현  ;  이영구  ;  김청수  ;  류수방  ;  김법완  ;  장성구  ;  김세중  ;  이현무  ;  최한용  ;  홍성준  ;  이강현  ;  송재만  ;  천 준  ;  윤성철  ;  정문기 
 Korean Journal of Urological Oncology (대한비뇨기종양학술지), Vol.7(1) : 21-26, 2009 
Journal Title
Korean Journal of Urological Oncology(대한비뇨기종양학술지)
Issue Date
Prostate cancer ; Leuprolide acetate ; Testosterone ; Prostate specific antigen
Purpose: We evaluated the efficacy and safety of monthly administrations of the luteinizing hormone-releasing hormone agonists leuprolide acetate depot (Luphereⓡ Depot inj 3.75mg) in patients with prostate cancer.

Materials and Methods: Between December 2005 and April 2006, 96 men with prostate cancer treated with leuprolide acetate 3.75mg. The agent was injected subcutaneously every four weeks for three injections. Primary endpoint was the percentage of men whose serum testosterone concentrations declined to and were maintained at or below castrate level (50ng/dl) during 12 weeks of treatment. Secondary endpoints were serum testosterone levels, the changes of prostate specific antigen (PSA) levels, the percentage of men whose prostate specific antigen levels were reached nadir after 12 weeks. Patients were monitored for clinical adverse events and laboratory abnormalities.

Results: The testosterone concentrations were maintained below castration levels in 89.02% of patients at 4-12 weeks. At baseline, the mean testosterone concentration was 427.32±172.35ng/dl. And the mean testosterone concentration decreased significantly 35.54±95.09ng/dl at 4 weeks, 15.94±44.65ng/dl at 8 weeks and 12.42±21.00 ng/dl at 12 weeks from baseline (p<0.001). At baseline, the mean PSA level was 76.88±335.71ng/ml. PSA level decreased to 15.79±50.99ng/ml at 4 weeks, 5.68±17.65ng/ml at 8 weeks and 3.59±10.72ng/ml at 12 weeks from baseline (p<0.001). The adverse events were flushing, increased sweating, and elevated liver enzymes. They are well-known adverse events of leuprolide acetate.

Conclusions: Leuprolide acetate 3.75mg reduced testosterone concentrations and maintained castration effectively. Leuprolide acetate 3.75mg was well tolerated with the majority of systemic adverse events being physiologic results of the suppression of testosterone. Therefore, the present findings suggest that leuprolide acetate 3.75mg is useful for treating men with prostate cancer.
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1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
Hong, Sung Joon(홍성준) ORCID logo https://orcid.org/0000-0001-9869-065X
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