A Phase 3, Multicenter, Open Label, Randomized Study Of Abarelix Versus Leuprolide Plus Daily Antiandrogen In Men With Prostate Cancer

No AccessJournal of UrologyCLINICAL UROLOGY: Original Articles1 Apr 2002A Phase 3, Multicenter, Open Label, Randomized Study Of Abarelix Versus Leuprolide Plus Daily Antiandrogen In Men With Prostate Cancer The Abarelix Study Group, John Trachtenberg, Marc Gittleman, Christopher Steidle, Winston Barzell, William Friedel, Dennis Pessis, Nick Fotheringham, Marilyn Campion, and Marc B. Garnick The Abarelix Study Group The Abarelix Study Group , John TrachtenbergJohn Trachtenberg , Marc GittlemanMarc Gittleman , Christopher SteidleChristopher Steidle , Winston BarzellWinston Barzell , William FriedelWilliam Friedel , Dennis PessisDennis Pessis , Nick FotheringhamNick Fotheringham , Marilyn CampionMarilyn Campion , and Marc B. GarnickMarc B. Garnick View All Author Informationhttps://doi.org/10.1016/S0022-5347(05)65175-0AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We compared the endocrinological and biochemical efficacy of abarelix depot, a gonadotropin-releasing hormone antagonist, with that of a widely used combination of luteinizing hormone releasing hormone agonist and a nonsteroidal antiandrogen. Materials and Methods: A total of 255 patients were randomized to receive open label 100 mg. abarelix depot or 7.5 mg. leuprolide acetate intramuscularly injection on days 1, 29, 57, 85, 113 and 141 for 24 weeks. Patients in the abarelix group received an additional injection on day 15 and those in the leuprolide acetate group received 50 mg. bicalutamide daily. Patients could continue treatment with study drug for an additional 28 weeks. The efficacy end points were the comparative rates of avoidance of testosterone surge (greater than 10% increase) within 7 days of the first injection and the rapidity of achieving reduction of serum testosterone to castrate levels (50 ng./dl. or less) on day 8. Patients were monitored for adverse events and laboratory abnormalities. Results: Abarelix was more effective in avoidance of testosterone surge (p <0.001) and the rapidity of reduction of testosterone to castrate levels on day 8 (p <0.001) than combination therapy. No significant difference was seen between the groups in the initial rate of decline of serum prostate specific antigen or the ability to achieve and maintain castrate levels of testosterone. No unusual or unexpected adverse events were reported. Conclusions: Abarelix as monotherapy achieves medical castration significantly more rapidly than combination therapy and avoids the testosterone surge characteristic of agonist therapy. Both treatments were equally effective in reducing serum prostate specific antigen, and achieving and maintaining castrate levels of testosterone. References 1 : Prevention of the transient adverse effects of a gonadotropin-releasing hormone analogue (buserelin) in metastatic prostatic carcinoma by administration of an antiandrogen (nilutamide). N Engl J Med1989; 321: 413. Google Scholar 2 : Simultaneous administration, a combination necessary for the use of LHRH agonists in the treatment of prostate cancer. Proc Natl Acad Sci USA1984; 81: 3861. Google Scholar 3 : Clinical study of leuprolide depot formulation in the treatment of advanced prostate cancer. The Leuprolide Study Group. J Urol1990; 143: 68. Abstract, Google Scholar 4 : Treatment of advanced prostatic cancer. Urol Clin North Am1987; 14: 353. 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Link, Google Scholar From the Princess Margaret Hospital, Toronto, Canada, South Florida Medical Research, Aventura and Urology Treatment Center, Sarasota, Florida, North Indiana Urology, Fort Wayne, Indiana, San Diego Urology Center, La Mesa and Amgen Inc., Thousand Oaks, California, Affiliated Urologists, Chicago, Illinois, and PRAECIS Pharmaceuticals Inc., Cambridge, Massachusetts© 2002 by American Urological Association, Inc.FiguresReferencesRelatedDetails Volume 167Issue 4April 2002Page: 1670-1674 Advertisement Copyright & Permissions© 2002 by American Urological Association, Inc.Keywordsprostatic neoplasmsleuprolidecastrationclinical trial, phase IIIMetrics Author Information The Abarelix Study Group Financial interest and/or other relationship with Amgen, PRAECIS, Merck, Pfizer, Alza, Bayer, Tap, Watson, Abbott, Glaxo, Vivus, Zoragen, Lilly-Icos, Yamanouchi and Zeneca. More articles by this author John Trachtenberg Financial interest and/or other relationship with Amgen. More articles by this author Marc Gittleman Financial interest and/or other relationship with Amgen, PRAECIS, Merck, Pfizer, Alza, Bayer, Tap, Watson, Abbott, Glaxo, Vivus, Zoragen, Lilly-Icos, Yamanouchi and Zeneca. Participants: Ronald Anderson, Tacoma, Washington; Bruce Blank, The Urology Clinic, Portland, Oregon; Stanley Brosman, Pacific Clinical Research, Santa Monica, California; Hugh Fischer, Albany Medical College, Albany, New York; L. Michael Glode, University of Colorado Health Sciences Center, Denver, Colorado; Peter Gordon, Nebraska Clinical Research Center, Omaha, Nebraska; Stuart Holden, Tower Urology Medical Group, Los Angeles, California; Robert Kahn, Pan Pacific Research, San Francisco, California; Scott McDougall, Massachusetts General Hospital, Boston, Massachusetts; James McMurray, Medical Affiliated Research Center, Huntsville, Alabama; William Moseley, San Diego Uro-Research, San Diego, California; Myron Murdock, 206 Research Associates, Greenbelt, Maryland; Mark Ratner, Mid-Atlantic Clinical Research, Rockville, Maryland; David Reed, PC3, Seattle, Washington; Gary Steinberg, University of Chicago, Chicago, Illinois; Alexander Vukasin, Urology Group of Princeton, Princeton, New Jersey; and David Wood, Wayne State University, Detroit, Michigan. More articles by this author Christopher Steidle Financial interest and/or other relationship with Amgen. More articles by this author Winston Barzell More articles by this author William Friedel More articles by this author Dennis Pessis Financial interest and/or other relationship with Merck, Olympus and PRAECIS. More articles by this author Nick Fotheringham Financial interest and/or other relationship with Amgen. More articles by this author Marilyn Campion Financial interest and/or other relationship with PRAECIS. More articles by this author Marc B. Garnick Financial interest and/or other relationship with Amgen and PRAECIS. More articles by this author Expand All Advertisement PDF downloadLoading ...