Adult urologyA phase 3, multicenter, open-label, randomized study of abarelix versus leuprolide acetate in men with prostate cancer22☆,
Section snippets
Material and methods
This multicenter trial was conducted at 26 sites in the United States. This report is an analysis of the first 84 days of treatment (through day 85) in 269 men.
Results
Two hundred sixty-nine men received abarelix (n = 180) or leuprolide acetate (n = 89). Ninety-eight percent of the abarelix group and 95% of the leuprolide acetate group completed treatment through day 85. The reasons for discontinuation before day 85 were patient decision and intolerable adverse events (1% versus 3% and 1% versus 2% for the abarelix and leuprolide acetate groups, respectively). No patient died during the study. The demographics of the patient population and baseline disease
Comment
This study comparatively evaluated abarelix with leuprolide acetate, a commonly used LHRH agonist, and demonstrated that these two hormonal agents have a fundamentally different mechanism of action and resultant hormonal and biochemical profile. Unlike the agonist class of agents that causes an initial stimulation of androgens before achieving androgen suppression, an antagonist avoids the initial testosterone surge, resulting in a more rapid onset of action in achieving medical castration. The
Acknowledgements
Acknowledgment. To Michele Vivirito, Wanda Krall, Ph.D., Mitzi Armstrong, Dora Menchaca, Ph.D., and MaryAnn Foote, Ph.D. for their assistance in writing this report.
References (5)
- et al.
Abarelix depot, a GnRH antagonist, vs leuprolide or goserelin, LHRH agonistsinitial results of endocrinologic and biochemical efficacy in patients with prostate cancer
J Urol
(2001) - et al.
Hormone-refractory prostate cancer cells express functional follicle-stimulating hormone receptor (FSHR)
J Urol
(1999)
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This study was funded through an unrestricted educational grant from Praecis Pharmaceuticals, Inc.
- 1
This article is dedicated to Dora Menchaca, Ph.D., from Amgen, Inc., a victim of hijacked American Airline Flight 77 that crashed into the Pentagon on September 11, 2001. Her devotion helped make this study possible.
- 3
D. McLeod, N. Zinner, K. Tomera, and D. Gleason are study investigators funded by Praecis Pharmaceuticals, Inc. N. Zinner is a paid consultant to Praecis Pharmaceuticals, Inc. M. Campion and M. Garnick hold stock in Praecis Pharmaceuticals, Inc. N. Fotheringham and M. Garnick hold stock in Amgen, Inc., which had a licensing agreement with Praecis Pharmaceuticals, Inc. for the distribution of the mentioned product.