1. ¹Urological Department, Städtisches Klinikum, Offenbach, Germany
2. ²ARCUS Pharma Consult, Konstanz, Germany

Correspondence: Professor UW Tunn, Department of Urology, Städtisches Klinikum Offenbach, Starkenburgring 66, Offenbach 63069, Germany. E-mail: Tunn@em.uni-frankfurt.de

Received 14 July 2008; Accepted 28 July 2008; Published online 25 November 2008.

Abstract

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 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.