Objectives. To compare the pharmacodynamics and tolerability of the ne
w goserelin acetate 10.8-mg depot with the 3.6-mg depot in patients wi
th advanced prostate cancer during the first 3 months of therapy. Meth
ods. One hundred sixty patients were randomized in two comparative stu
dies to receive either the 10.8-mg goserelin acetate depot every 12 we
eks or the 3.6-mg goserelin acetate depot every 4 weeks for 12 weeks a
nd then the 10.8-mg depot every 12 weeks thereafter. Data for pharmaco
dynamic assessments were collected prospectively, whereas clinical res
ponse data were collected retrospectively. Results. Serum testosterone
profiles of the 10.8-mg goserelin acetate depot and the 3.6-mg gosere
lin acetate depot were similar; testosterone levels in both groups fel
l below castrate levels by day 21 after administration. Decreases in s
erum prostate-specific antigen level after 3 months of therapy were al
so similar in both groups: 94% with the 10.8-mg depot and 92.5% with t
he 3.6-mg depot, For all patients, the median time to progression was
152.7 weeks and the median time to death was 213.6 weeks, The safety p
rofile of the 10.8-mg goserelin acetate depot was similar to that of t
he 3.6-mg depot; hot flashes was the most common adverse event. The in
cidence of injection site reactions was very low (2 [0.3%] of 614 admi
nistrations). Conclusions, The new 10.8-mg depot was pharmacodynamical
ly equivalent to the current 3.6-mg depot and was well tolerated, both
locally and systemically. The observed times to progression and survi
val were as expected in this patient population. The 10.8-mg goserelin
-acetate depot provided a dosing schedule that was convenient for the
patient and the physician, and it has the potential to reduce health c
are costs while maintaining the quality of life in patients being trea
ted for advanced prostate cancer. Copyright 1996 by Elsevier Science I
nc.