EFFICACY AND SAFETY OF LEUPRORELIN ACETATE DEPOT FOR PROSTATE-CANCER

In an open, prospective clinical trial enrolling 205 patients, efficac y and safety of the gonadotropin-releasing hormone agonist leuprorelin acetate depot (LAD) in the treatment of patients with advanced prosta tic carcinoma were assessed. 3.75 mg of the LAD formulation was inject ed subcutaneously in monthly intervals. The primary objective of this study was to evaluate the efficacy of the analogue in producing and ma intaining castration levels of testosterone over a > 3-year follow-up period and to determine its safety profile. Median pretreatment serum testosterone levels fell from 350 to 21 ng/dl after 4 weeks and 20 ng/ dl after 45 months. The long-term clinical efficacy of the LAD formula tion can be expressed by best treatment response over time. These resp ective figures read as follows: 10.7% complete response; 49.8% partial response; 34.1% no change; 1.5% progression, and 3.9% no data availab le. The median time to progression was 12 (15 +/- 11) months. Median s urvival time calculated by Kaplan-Meier exceeded 42.5 months for patie nts on monotherapy and 30.9 months for those on combination therapy. H ot flushes which were related to androgen deprivation were the most co mmon side effects. Patients and treating physicians judged tolerabilit y of LAD in more than 90% as good. Androgen deprivation remains the ma instay of hormone-dependent advanced carcinoma of the prostate. Up to now, surgical castration has been considered the standard method. LAD is an advantage in the endocrine treatment of advanced prostatic carci noma and is a good alternative to castration.