Safety and clinical efficacy of a new 6-month depot formulation of leuprorelin acetate in patients with prostate cancer in Europe.

This multicentre European study compared the safety and tolerability of the existing 11.25 mg 3-month depot of leuprorelin acetate with a new 30 mg 6-month depot in men with newly diagnosed prostate cancer or prostate-specific antigen relapse after radiotherapy or prostatectomy. The primary end points were safety and tolerability and secondary end points were clinical response based on European Organization for Research and Treatment of Cancer (EORTC) criteria and response rate by time point for testosterone suppression (castrate level <or=50 ng per 100 ml). Results showed that the incidence of adverse events was similar with the different depot formulations, with hot flushes being the most common. The assessment of EORTC response criteria showed comparable results in each arm with a tumour progression rate of <10% at the final examination at month 12. Testosterone suppression was comparable with the different formulations. In conclusion, the 6-month depot formulation of leuprorelin acetate containing 30 mg is well tolerated and safe and has been shown to be as effective as the widely used 3-month depot containing 11.25 mg leuprorelin acetate in the treatment of prostate cancer.

RCT Entities:   Population Interventions Outcomes