A 1-Year, Open Label, Randomized Phase II Dose Finding Study of Degarelix for the Treatment of Prostate Cancer in North America

Journal of Urology

Volumn 180, Issue 5, 2008, Pages 1986-1992

  Gittelman, Marc ^a   Pommerville, Peter J ^b   Persson, Bo Eric ^c   Jensen, Jens Kristian ^c   Olesen, Tine Kold ^c  

^a South Florida Medical Research   (United States)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c Ferring Pharmaceuticals AS   (Denmark)

Author keywords

adenocarcinoma; gonadotropin releasing hormone; prostate; prostate specific antigen; testosterone

Indexed keywords

DEGARELIX; LUTEINIZING HORMONE; PROSTATE SPECIFIC ANTIGEN; TESTOSTERONE;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; HUMAN; INJECTION SITE URTICARIA; LUTEINIZING HORMONE BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NORTH AMERICA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; TESTOSTERONE BLOOD LEVEL; TREATMENT DURATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

EID: 53249121469     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.juro.2008.07.033     Document Type: Article

References (21)

1. Jemal A., Siegel R., Ward E., Murray T., Xu J., and Thun M.J. Cancer statistics, 2007. CA Cancer J Clin 57 (2007) 43
2. Heidenreich A., Aus G., Bolla M., Joniau S., Matveev V.B., Schmid H.P., et al. EAU guidelines on prostate cancer. Eur Urol 53 (2008) 68
3. Nett T.M., Crowder M.E., Moss G.E., and Duello T.M. GnRH-receptor interaction. V. Down-regulation of pituitary receptors for GnRH in ovariectomized ewes by infusion of homologous hormone. Biol Reprod 24 (1981) 1145
4. Heber D., Dodson R., Stoskopf C., Peterson M., and Swerdloff R.S. Pituitary desensitization and the regulation of pituitary gonadotropin-releasing hormone (GnRH) receptors following chronic administration of a superactive GnRH analog and testosterone. Life Sci 30 (1982) 2301
5. Conn P.M., and Crowley Jr. W.F. Gonadotropin-releasing hormone and its analogues. N Engl J Med 324 (1991) 93
6. Lepor H. Comparison of single-agent androgen suppression for advanced prostate cancer. Rev Urol 7 (2005) S3
7. Sasagawa I., Kubota Y., Nakada T., Suzuki H., Hirano J., Sugano O., et al. Influence of luteinizing hormone-releasing hormone analogues on serum levels of prostatic acid phosphatase and prostatic specific antigen in patients with metastatic carcinoma of the prostate. Int Urol Nephrol 30 (1998) 745
8. Tomera K., Gleason D., Gittelman M., Moseley W., Zinner N., Murdoch M., et al. The gonadotropin-releasing hormone antagonist abarelix depot versus luteinizing hormone releasing hormone agonists leuprolide or goserelin: initial results of endocrinological and biochemical efficacies in patients with prostate cancer. J Urol 165 (2001) 1585
9. 6-LHRH analogue in patients with metastatic prostatic cancer. Lancet 1 (1984) 971
10. Broqua P., Riviere P.J., Conn P.M., Rivier J.E., Aubert M.L., and Junien J.L. Pharmacological profile of a new, potent, and long-acting gonadotropin-releasing hormone antagonist: degarelix. J Pharmacol Exp Ther 301 (2002) 95
11. Jiang G., Stalewski J., Galyean R., Dykert J., Schteingart C., Broqua P., et al. GnRH antagonists: a new generation of long acting analogues incorporating p-ureido-phenylalanines at positions 5 and 6. J Med Chem 44 (2001) 453
12. Schwach G., Oudry N., Delhomme S., Lück M., Lindner H., and Gurny R. Biodegradable microparticles for sustained release of a new GnRH antagonist - part I: screening commercial PLGA and formulation technologies. Eur J Pharm Biopharm 56 (2003) 327
13. Schwach G., Oudry N., Giliberto J.-P., Broqua P., Lück M., Lindner H., et al. Biodegradable PLGA microparticles for sustained release of a new GnRH antagonist: part II. In vivo performance. Eur J Pharm Biopharm 57 (2004) 441
14. Koechling W. Effect of various GnRH antagonists on histamine release from human skin. Presented at the 8th International Symposium on GnRH Analogues in Cancer and Human Reproduction. Salzburg, Austria (February 10-13, 2005)
15. Balchen T., Agersø H., Olesen T.K., Jensen J.K., and Senderovitz T. Pharmacokinetics, pharmacodynamics, and safety of a novel fast-acting gonadotropin-releasing hormone receptor blocker, degarelix, in healthy men. Presented at the 8th International Symposium on GnRH Analogues in Cancer and Human Reproduction. Salzburg, Austria (February 10-13, 2005)
16. Van Poppel H., Tombal B., de la Rosette J.J., Persson B.E., Jensen J.K., and Kold Olesen T. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker-results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol 54 (2008) 805
17. Weston P., Hammonds J., Vaughton K., Olesen T.K., Jensen J.K., Eskerod O., et al. Degarelix: a novel GnRH antagonist tested in a multicenter, randomized dose-finding study in prostate cancer patients. BJU Int 94 suppl. (2004) 57
18. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. (Amended by the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000; notes of clarification issued in 2002 and 2004).
19. FDA Working Group. CDER-PhRMA-AASLD Conference 2000: Clinical White Paper on Drug-induced Hepatotoxicity, November 2000.
20. Koch M., Steidle C., Brosman S., Centeno A., Gaylis F., and Campion M. An open-label study of abarelix in men with symptomatic prostate cancer at risk of treatment with LHRH agonists. Urology 62 (2003) 877
21. Zinner N.R., Bidair M., Centeno A., and Tomera K. Similar frequency of testosterone surge after repeat injections of goserelin (Zoladex) 3.6 mg and 10.8 mg: results of a randomized open-label trial. Urology 64 (2004) 1177