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Investigational GnRH Antagonist Reduces PSA Without Hormonal Surge

Investigational GnRH Antagonist Reduces PSA Without Hormonal Surge

ANAHEIM, California—Abarelix, an injectable gonadotropin-releasing
hormone (GnRH) antagonist, reduces serum prostate-specific antigen (PSA) levels
and testosterone levels more than standard therapy, with less hormonal
"surge," according to several studies presented at the American
Urological Association (AUA) annual meeting.

Abarelix depot is currently under priority review by the FDA for the
treatment of prostate cancer. "Abarelix represents a completely unique
hormonal therapy for prostate cancer. It is rapid acting, without a
testosterone surge," commented Dennis Pessis, MD, associate professor of
urology, Rush-Presbyterian-St. Luke’s Medical Center, Chicago. Dr. Pessis
reported the findings for the Abarelix Study Group.

No Need for Combination Therapy

Antiandrogens are frequently coadministered with luteinizing
hormone-releasing hormone (LHRH) agonists to mitigate the effects of the
androgen and gonadotropin surge and the consequent potential clinical flare
associated with the use of LHRH agonists alone.

Abarelix monotherapy is devoid of this initial surge and, therefore, could
potentially eliminate the cost, noncompliance, and inconvenience associated
with combined therapies, Dr. Pessis pointed out.

At the meeting, he reported the results of a head-to-head phase III trial
(abstract 685) of 251 early- and late-stage prostate cancer patients randomized
to abarelix (n = 168) or leuprolide acetate (Lupron) plus bicalutamide (Casodex)
(n = 83) for 24 weeks. Abarelix and the leuprolide combination were
administered every 4 weeks by intramuscular injection, with an additional
injection of abarelix given on day 15.

Serum levels of testosterone, dihydrotestosterone, luteinizing hormone (LH),
and follicle-stimulating hormone (FSH) were measured throughout the course of
the study.

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