Is high-dose leuprorelin acetate effective and safe in asian men with prostate cancer? An open-label, non-comparative, multi-center clinical trial.

Abstract

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.

• Authors: Seung-Hwan Lee, Hyun-Moo Lee, Sae-Woong Kim, Eun-Sik Lee, Sung-Joon Hong, Choung-Soo Kim, Taek-Won Kang, Byung-Ha Chung
• Journal: Yonsei medical journal (Yonsei Med J) Vol. 55 Issue 2 Pg. 310-5 (Mar 2014) ISSN: 1976-2437 [Electronic] Korea (South)
• PMID: 24532497 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Hormonal
• Testosterone
• Prostate-Specific Antigen
• Leuprolide

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Agents, Hormonal (administration & dosage, adverse effects, therapeutic use)
• Asian People
• Drug Administration Schedule
• Hot Flashes (chemically induced)
• Humans
• Leuprolide (administration & dosage, adverse effects, therapeutic use)
• Male
• Middle Aged
• Penis (drug effects)
• Prostate-Specific Antigen (blood)
• Prostatic Neoplasms (drug therapy)
• Testis (drug effects)
• Testosterone (blood)
• Treatment Outcome