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• W4376453286 abstract "No AccessJournal of UrologyCLINICAL UROLOGY: Original Articles1 May 2001THE 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 KEVIN TOMERA, DONALD GLEASON, MARC GITTELMAN, WILLIAM MOSELEY, NORMAN ZINNER, MYRON MURDOCH, MANI MENON, MARILYN CAMPION, MARC B. GARNICK, and FOR THE ABARELIX STUDY GROUP§ KEVIN TOMERAKEVIN TOMERA More articles by this author , DONALD GLEASONDONALD GLEASON More articles by this author , MARC GITTELMANMARC GITTELMAN Financial interest and/or other relationship with Alza Pharmaceuticals, Amgen, Merck, Otsuka, Pfizer, Pharmacia Upjohn, TAP Pharmaceuticals and Theratech, Inc. More articles by this author , WILLIAM MOSELEYWILLIAM MOSELEY Financial interest and/or other relationship with Amgen and/or Praecis Pharmaceuticals Inc. More articles by this author , NORMAN ZINNERNORMAN ZINNER Financial interest and/or other relationship with Bayer, Pfizer and Seminar Planet.com. More articles by this author , MYRON MURDOCHMYRON MURDOCH Financial interest and/or other relationship with Amgen and/or Praecis Pharmaceuticals Inc. More articles by this author , MANI MENONMANI MENON More articles by this author , MARILYN CAMPIONMARILYN CAMPION Financial interest and/or other relationship with Amgen and/or Praecis Pharmaceuticals Inc. More articles by this author , MARC B. GARNICKMARC B. GARNICK Financial interest and/or other relationship with Amgen and/or Praecis Pharmaceuticals Inc. More articles by this author , and FOR THE ABARELIX STUDY GROUP§ Participants: Stephen Auerbach, California Professional Research, Newport Beach, California; C. Gilberto Brito, Advanced Clinical Therapeutics, Phoenix, Arizona; Stanley Brosman, Pacific Clinical Research, Santa Monica, California; Arthur Centeno, Urology San Antonio Research, San Antonio, Texas; Stacy Childs, Wyoming Research Foundation, Cheyenne, Wyoming; Robert Feldman, Urology Specialists, Waterbury, Connecticut; William Friedel, San Diego Urology Center, Las Mesa, California; Michael Glode, Colorado University Cancer Center, Denver, Colorado; Robert Kahn, Pan Pacific Research, San Francisco, California; Ira Klimberg, Urology Center of Florida, Ocala, Florida; James McMurray, Medical Affiliated Research, Huntsville, Alabama; Roohollah Sharifi, University of Illinois, Chicago, Illinois; and Christopher Steidle, Northeast Indiana Research, Fort Wayne, Indiana. More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(05)66353-7AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We contrasted the endocrinological and biochemical efficacies of abarelix depot, a pure gonadotropin-releasing hormone antagonist, with a prospective concurrent control cohort receiving luteinizing hormone releasing hormone (LH-RH) agonists with or without antiandrogen for treatment of patients with prostate cancer receiving initial hormonal therapy. Materials and Methods: In this phase 2 open label study 242 patients with prostate cancer requiring initial hormonal treatment received abarelix depot (209) or LH-RH agonists (33) with or without antiandrogen. A total of 100 mg. abarelix depot was delivered intramuscularly every 28 days with an additional injection on day 15. LH-RH agonists with or without antiandrogen were administered according to the depot formulation used. Endocrine efficacy was measured by the absence of testosterone surge and rapidity of castration onset. The rate of prostate specific antigen decrease was assessed. Results: No patient treated with abarelix depot had testosterone surge during week 1 compared with 82% of those treated with LH-RH agonists. The concomitant administration of antiandrogen had no effect. During the first week of drug administration, in 75% of patients treated with abarelix depot and in 0% of those treated with LH-RH agonist medical castration was achieved. Prostate specific antigen decrease was faster, with no flare or surge in patients treated with abarelix depot. Abarelix depot was well tolerated. Conclusions: Abarelix depot represents a new class of hormonal therapy, gonadotropin releasing hormone antagonists, that has rapid medical castration and avoids the testosterone surge characteristic of LH-RH agonists. References 1 : Studies on prostate cancer. I. The effect of castration, estrogen and of androgen injections on serum phosphatase in metastatic carcinoma of the prostate. Recent Results Cancer Res1941; 1: 293. Google Scholar 2 : Leuprolide versus diethylstilbesterol for metastatic prostate cancer. N Engl J Med1984; 311: 1281. Google Scholar 3 : Prevention of the transient adverse effects of gonadotropin-releasing hormone analogue (buserelin) in metastatic prostatic carcinoma by administration of antiandrogen (nilutamide). N Engl J Med1989; 321: 413. Google Scholar 4 : Influence of different types of antiandrogens on luteinizing hormone-releasing hormone analogue-induced testosterone surge in patients with metastatic carcinoma of the prostate. J Urol1990; 144: 934. Google Scholar 5 : Sudden death due to disease flare with luteinizing hormone-releasing hormone agonist therapy for carcinoma of the prostate. J Urol1990; 144: 1479. Link, Google Scholar 6 : Suppression of plasma gonadotropins by abarelix: a potent new LHRH antagonist. Mol Urol1998; 2: 265. Google Scholar 7 : Differential response of prostate specific antigen to testosterone surge after luteinizing hormone-releasing hormone analogue in prostate cancer and benign prostatic hyperplasia. BJU Int2000; 85: 690. Google Scholar 8 : Antiandrogens: a summary review of pharmacodynamic properties and tolerability in prostate cancer therapy. Arch Ital Urol Androl1999; 71: 293. Google Scholar 9 : Tailoring of hormonal therapy in prostate cancer. Prostate Ca Prostatic Dis2000; 3: 21. Google Scholar From the Alaska Clinical Research Center, Anchorage, Alaska, Advanced Clinical Therapeutics, Tucson, Arizona, South Florida Medical Research, Aventura, Florida, San Diego Uro-Research, San Diego and Western Clinical Research, Inc., Torrance, California, 206 Research Associates, Greenbelt, Maryland, Henry Ford Hospital, Detroit, Michigan, and Praecis Pharmaceuticals Inc., Cambridge, Massachusetts© 2001 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byMorgentaler A (2018) Testosterone Therapy in Men With Prostate Cancer: Scientific and Ethical ConsiderationsJournal of Urology, VOL. 189, NO. 1S, (S26-S33), Online publication date: 1-Jan-2013.Morgentaler A (2009) Testosterone Therapy in Men With Prostate Cancer: Scientific and Ethical ConsiderationsJournal of Urology, VOL. 181, NO. 3, (972-979), Online publication date: 1-Mar-2009.Gittelman M, Pommerville P, Persson B, Jensen J and Olesen T (2008) A 1-Year, Open Label, Randomized Phase II Dose Finding Study of Degarelix for the Treatment of Prostate Cancer in North AmericaJournal of Urology, VOL. 180, NO. 5, (1986-1992), Online publication date: 1-Nov-2008.The Abarelix Study Group , Trachtenberg J, Gittleman M, Steidle C, Barzell W, Friedel W, Pessis D, Fotheringham N, Campion M and Garnick M (2018) A Phase 3, Multicenter, Open Label, Randomized Study Of Abarelix Versus Leuprolide Plus Daily Antiandrogen In Men With Prostate CancerJournal of Urology, VOL. 167, NO. 4, (1670-1674), Online publication date: 1-Apr-2002. Volume 165Issue 5May 2001Page: 1585-1589 Advertisement Copyright & Permissions© 2001 by American Urological Association, Inc.Keywordshormonesprostatic neoplasmstherapeuticsandrogen antagonistsgonadorelinMetricsAuthor Information KEVIN TOMERA More articles by this author DONALD GLEASON More articles by this author MARC GITTELMAN Financial interest and/or other relationship with Alza Pharmaceuticals, Amgen, Merck, Otsuka, Pfizer, Pharmacia Upjohn, TAP Pharmaceuticals and Theratech, Inc. More articles by this author WILLIAM MOSELEY Financial interest and/or other relationship with Amgen and/or Praecis Pharmaceuticals Inc. More articles by this author NORMAN ZINNER Financial interest and/or other relationship with Bayer, Pfizer and Seminar Planet.com. More articles by this author MYRON MURDOCH Financial interest and/or other relationship with Amgen and/or Praecis Pharmaceuticals Inc. More articles by this author MANI MENON More articles by this author MARILYN CAMPION Financial interest and/or other relationship with Amgen and/or Praecis Pharmaceuticals Inc. More articles by this author MARC B. GARNICK Financial interest and/or other relationship with Amgen and/or Praecis Pharmaceuticals Inc. More articles by this author FOR THE ABARELIX STUDY GROUP§ Participants: Stephen Auerbach, California Professional Research, Newport Beach, California; C. Gilberto Brito, Advanced Clinical Therapeutics, Phoenix, Arizona; Stanley Brosman, Pacific Clinical Research, Santa Monica, California; Arthur Centeno, Urology San Antonio Research, San Antonio, Texas; Stacy Childs, Wyoming Research Foundation, Cheyenne, Wyoming; Robert Feldman, Urology Specialists, Waterbury, Connecticut; William Friedel, San Diego Urology Center, Las Mesa, California; Michael Glode, Colorado University Cancer Center, Denver, Colorado; Robert Kahn, Pan Pacific Research, San Francisco, California; Ira Klimberg, Urology Center of Florida, Ocala, Florida; James McMurray, Medical Affiliated Research, Huntsville, Alabama; Roohollah Sharifi, University of Illinois, Chicago, Illinois; and Christopher Steidle, Northeast Indiana Research, Fort Wayne, Indiana. More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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