Fm. Debruyne et al., A NEW LONG-ACTING FORMULATION OF THE LUTEINIZING-HORMONE-RELEASING HORMONE ANALOG, GOSERELIN - RESULTS OF STUDIES IN PROSTATE-CANCER, The Journal of urology, 155(4), 1996, pp. 1352-1354
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.