RANDOMIZED OPEN LABELED COMPARATIVE-STUDY OF THE EFFICACY, SAFETY ANDTOLERABILITY OF LEUPRORELIN ACETATE 1M AND 3M DEPOT IN PATIENTS WITH ADVANCED PROSTATIC-CANCER

Objectives: In a European, prospective, 1:2 randomized phase II multic entre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficac y and safety. Methods: Standard clinical investigations and methods we re employed in the study. Leuprorelin levels were determined using a s pecially modified RIA. Results: The two formulations produced virtuall y identical effects with a pronounced fall in testosterone and gonadot ropin serum levels and a marked reduction in PSA levels. After 9 month s' treatment, PSA was normalized(less than or equal to 4 ng/ml) in 65. 2 and 66.1% of the 1M and 3M depot patients, respectively. The best re sponse to 1M vs. 3M depot during the study was as follows: complete re mission in 5 vs. 5.7%, partial remission in 36.3 vs. 33.8% and stabili zation in 40.0 vs. 40.8%. The main side effects of both formulations w ere related to androgen deprivation. Conclusions: Comparable results w ere recorded for the two formulations of leuprorelin acetate in terms of clinical response, endocrine effects and tolerability. The newly de veloped leuprorelin acetate 3M depot, as a refinement of the establish ed 1M depot, offers an opportunity to improve patient compliance and p rovides individualized and optimized, patient-orientated treatment by reducing the number of injections to four per year.