To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Degarelix Shows Similar Efficacy to Leuprolide in Prostate Cancer Patients But With Faster Testosterone Suppression: Presented at EAU URL: http://www.pslgroup.com/dg/21EF5E.htm Doctor's Guide April 1, 2008
By Jill Stein MILAN, Italy -- April 1, 2008 -- The investigational gonadotropin-releasing hormone (GnRH) blocker degarelix is as effective as standard androgen-deprivation therapy (ADT) in men with advanced prostate cancer, according to research presented here at the 23rd Annual Congress of the European Association of Urology (EAU 2008). However, the data from a phase 3 study also showed that use of the GnRH blocker is associated with more rapid, profound, and sustained testosterone suppression, said lead investigator Laurent Boccon-Gibod, MD, Professor of Urology, Centre Hospitalier Universitaire Hôpital Bichat-Claude Bernard, Paris, France. Dr. Boccon-Gibod and colleagues compared the efficacy and safety of degarelix with the GnRH agonist leuprolide depot 7.5 mg/day over 12 months in 610 men with histologically confirmed adenocarcinoma of the prostate for whom androgen deprivation was indicated. The trial excluded patients requiring neoadjuvant hormonal therapy. "While GnRH agonists are the mainstay of ADT for prostate cancer, they are associated with late onset of testosterone and prostate-specific antigen (PSA) reduction, and an initial hormone surge that boosts the risk of tumour stimulation," Dr. Boccon-Gibod stated. Patients were assigned to 1 of 3 dosing regimens: a degarelix subcutaneous starting dose of 240 mg (40 mg/mL) for 1 month followed by monthly maintenance doses of 160 mg (40 mg/mL; group A, n=202) or 80 mg (20 mg/mL; group B, n=207); or monthly intramuscular injections of leuprolide depot 7.5 mg (group C, n=201). Patients in group C could use bicalutamide for clinical flare protection. Treatment response was defined as suppression of testosterone levels to no greater than 0.5 ng/mL at all monthly measurements from day 28 to day 364. The study was designed to demonstrate statistical noninferiority of degarelix versus leuprolide 7.5 mg for treatment response. Results showed that both doses of degarelix were at least as effective as leuprolide in terms of response to treatment. Degarelix demonstrated a quicker onset of action. Overall, 95.5% and 96% of men in the degarelix 160 and 80 mg groups, respectively, had testosterone levels of <0.5 ng/mL on day 3, compared with none of the patients in the leuprolide group. The experimental drug did not cause a testosterone surge or microsurge, and PSA levels decreased more rapidly with degarelix than with leuprolide. "EAU guidelines state that all ADTs should be rated against the effects of surgical castration," commented John Anderson, MD, Consultant Urologic Surgeon, Royal Hallamshire Hospital, Sheffield, United Kingdom, who did not participate in this research. "The results of this study demonstrate that the GnRH blocker's extremely rapid and sustained reduction in testosterone rivals that of surgery." Prostate cancer is the most common cancer among men in developed countries and the third most prevalent cancer worldwide. Funding for this study was provided by Ferring Pharmaceuticals. [Presentation title: Degarelix Compared to Leuprolide Depot 7.5 mg in a 12-Month Randomised, Open-Label, Parallel-Group Phase III Study in Prostate Cancer Patients. Abstract 537] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.