A NEW LONG-ACTING FORMULATION OF THE LUTEINIZING-HORMONE-RELEASING HORMONE ANALOG, GOSERELIN - RESULTS OF STUDIES IN PROSTATE-CANCER

Purpose: To assess the pharmacodynamic equivalence of the new 10.8 mg, goserelin depot with the current 3.6 mg. depot 3 studies were perform ed in patients with advanced prostate cancer. Materials and Methods: I n 2 comparative studies 160 patients were randomized for dosing every 12 weeks using the 10.8 mg, depot or every 4 weeks using the 3.6 mg. d epot. In the noncomparative study 35 patients received the 10.8 mg. de pot. Blood sampling for serum testosterone and evaluation of toxicity was done during the 48-week study period. Results: Serum testosterone profiles of the 10.8 and 3.6 mg. goserelin depots were similar with te stosterone levels decreasing into the castrate range by day 21 after d epot administration. The safety profile of 10.8 mg. goserelin is compa rable to that of the current monthly depot with the main side effects related to androgen deprivation. Conclusions: The new long acting depo t was pharmacologically equivalent, and well tolerated locally and sys temically, and will offer added convenience to patients and health car e personnel.