PMID- 24532497
OWN - NLM
STAT- MEDLINE
DCOM- 20140929
LR  - 20221207
IS  - 1976-2437 (Electronic)
IS  - 0513-5796 (Print)
IS  - 0513-5796 (Linking)
VI  - 55
IP  - 2
DP  - 2014 Mar
TI  - Is high-dose leuprorelin acetate effective and safe in asian men with prostate 
      cancer? An open-label, non-comparative, multi-center clinical trial.
PG  - 310-5
LID - 10.3349/ymj.2014.55.2.310 [doi]
AB  - 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.
FAU - Lee, Seung-Hwan
AU  - Lee SH
AD  - Department of Urology, Gangnam Severance Hospital, Yonsei University College of 
      Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Korea. chung646@yuhs.ac.
FAU - Lee, Hyun-Moo
AU  - Lee HM
FAU - Kim, Sae-Woong
AU  - Kim SW
FAU - Lee, Eun-Sik
AU  - Lee ES
FAU - Hong, Sung-Joon
AU  - Hong SJ
FAU - Kim, Choung-Soo
AU  - Kim CS
FAU - Kang, Taek-Won
AU  - Kang TW
FAU - Chung, Byung-Ha
AU  - Chung BH
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Korea (South)
TA  - Yonsei Med J
JT  - Yonsei medical journal
JID - 0414003
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 3XMK78S47O (Testosterone)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
RN  - EFY6W0M8TG (Leuprolide)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents, Hormonal/*administration & dosage/adverse 
      effects/therapeutic use
MH  - Asian People
MH  - Drug Administration Schedule
MH  - Hot Flashes/chemically induced
MH  - Humans
MH  - Leuprolide/*administration & dosage/adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Penis/drug effects
MH  - Prostate-Specific Antigen/blood
MH  - Prostatic Neoplasms/*drug therapy
MH  - Testis/drug effects
MH  - Testosterone/blood
MH  - Treatment Outcome
PMC - PMC3936644
OTO - NOTNLM
OT  - Prostate cancer
OT  - adverse events
OT  - luteinizing hormone releasing hormone agonist
COIS- The authors have no financial conflicts of interest.
EDAT- 2014/02/18 06:00
MHDA- 2014/09/30 06:00
PMCR- 2014/03/01
CRDT- 2014/02/18 06:00
PHST- 2014/02/18 06:00 [entrez]
PHST- 2014/02/18 06:00 [pubmed]
PHST- 2014/09/30 06:00 [medline]
PHST- 2014/03/01 00:00 [pmc-release]
AID - 201403310 [pii]
AID - 10.3349/ymj.2014.55.2.310 [doi]
PST - ppublish
SO  - Yonsei Med J. 2014 Mar;55(2):310-5. doi: 10.3349/ymj.2014.55.2.310.