Clinical studies investigating the use of leuprorelin for prostate cancer in Asia

Background: Leuprorelin is a well-established treatment for prostate cancer (PCa); however, there is limited information on its use in Asian males. This review of English language publications between January 2000 and 2016 describes the outcomes of clinical trials on leuprorelin in Asian males with PCa of any grade, stage, or histopathology. Methods: The literature search was undertaken using PubMed, Cochrane Library, and ClinicalTrials.gov databases. Results: We identified nine studies from Japan, two studies from South Korea, and one international, multisite study which included Asian sites, with a total of 1,652 males previously diagnosed with PCa. All studies included subcutaneous or depot administration of leuprorelin at varying dose levels including 3.75 mg four weekly, 11.25 mg 12 weekly, or 22.5 mg every 12 or 24 weeks. Leuprorelin was administered as monotherapy or in combination with chemotherapy or hormonal therapy. Leuprorelin appears well tolerated in Asian males and is effective in reducing serum testosterone to castration levels (<50 ng/dL (<1.7 nmol/L)) and prostate-specific antigen levels. Common adverse events included hot flushes and mild hepatic dysfunction. Leuprorelin was shown to provide reasonable survival rates in PCa (T1b-T3N0M0) and in metastatic disease; another reasonable option for these patients is radiation therapy. Leuprorelin treatment also improved the quality of life. Conclusion: Leuprorelin may be an appropriate and efficacious treatment for males with PCa (T1b-T3N0M0). Leuprorelin treatment was well tolerated and associated with improvement in the quality of life.