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

2008; Lippincott Williams & Wilkins; Volume: 180; Issue: 5 Linguagem: Inglês

10.1016/j.juro.2008.07.033

1527-3792

Marc Gittelman, Peter Pommerville, Bo‐Eric Persson, Jens-Kristian Jensen, Tine Kold Olesen,

Prostate Cancer Diagnosis and Treatment

No AccessJournal of UrologyAdult Urology1 Nov 2008A 1-Year, Open Label, Randomized Phase II Dose Finding Study of Degarelix for the Treatment of Prostate Cancer in North America Marc Gittelman, Peter J. Pommerville, Bo-Eric Persson, Jens-Kristian Jensen, Tine Kold Olesen, and Degarelix Study Group Marc GittelmanMarc Gittelman Department of Urology, South Florida Medical Research, Aventura, Florida , Peter J. PommervillePeter J. Pommerville Department of Urological Sciences, University of British Columbia, Victoria, British Columbia , Bo-Eric PerssonBo-Eric Persson Department of Global Marketing, Ferring Pharmaceuticals A/S, Copenhagen, Denmark , Jens-Kristian JensenJens-Kristian Jensen Clinical R&D, Ferring Pharmaceuticals A/S, Copenhagen, Denmark , Tine Kold OlesenTine Kold Olesen Clinical R&D, Ferring Pharmaceuticals A/S, Copenhagen, Denmark , and Degarelix Study Group View All Author Informationhttps://doi.org/10.1016/j.juro.2008.07.033AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Degarelix is a gonadotropin-releasing hormone receptor antagonist (blocker) with rapid onset of action suppressing gonadotropins, testosterone and prostate specific antigen in prostate cancer. In the present open label, randomized study in North America we evaluated the efficacy and safety of a starting dose of 200 mg degarelix followed by monthly injections of 60 or 80 mg during 1 year of prostate cancer treatment. Materials and Methods: A total of 127 patients (median age 76 years, range 47 to 93) with histologically confirmed prostate cancer were enrolled in the study. Efficacy was assessed by measuring serum testosterone and prostate specific antigen. Results: Median baseline testosterone and prostate specific antigen levels were 4.13 ng/ml (P25–P75 3.03–5.11) and 13.4 ng/ml (P25–P75 6.80–25.7), respectively. The starting dose induced a rapid suppression of testosterone in that 88% of the patients had testosterone levels of 0.5 ng/ml or less 1 month after the injection. For patients who had testosterone levels of 0.5 ng/ml or less after 1 month, 93% and 98% of those receiving maintenance doses of 60 and 80 mg, respectively, had testosterone levels that were consistently 0.5 ng/ml or less at all monthly measurements from 1 month to 1 year. No evidence of testosterone surge was detected. In both groups prostate specific antigen decreased by 96% after 1 year and median time to 90% reduction in prostate specific antigen was 56 days. Six patients (5%) withdrew from the study due to adverse events. Conclusions: Degarelix treatment for 1 year resulted in a fast, profound and sustained suppression of testosterone and prostate specific antigen with no evidence of testosterone surge. Degarelix was well tolerated. References 1 : Cancer statistics, 2007. CA Cancer J Clin2007; 57: 43. Google Scholar 2 : EAU guidelines on prostate cancer. Eur Urol2008; 53: 68. Google Scholar 3 : GnRH-receptor interaction: V. 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Google Scholar © 2008 by American Urological AssociationFiguresReferencesRelatedDetailsCited bySmith M, Klotz L, Persson B, Olesen T and Wilde A (2010) Cardiovascular Safety of Degarelix: Results From a 12-Month, Comparative, Randomized, Open Label, Parallel Group Phase III Trial in Patients With Prostate CancerJournal of Urology, VOL. 184, NO. 6, (2313-2319), Online publication date: 1-Dec-2010. Volume 180Issue 5November 2008Page: 1986-1992 Advertisement Copyright & Permissions© 2008 by American Urological AssociationKeywordstestosteroneprostate-specific antigengonadotropin-releasing hormoneadenocarcinomaprostateAcknowledgmentsThese investigators provided assistance: Cal Andreou, Dr. Cal Andreou Research, Surrey, BC; Stanley Brosman, Pacific Clinical Research, Santa Monica, CA; Richard Casey, The Male Health Centers, Oakville, ON; Ronald Castellanos, SW Florida Urological Associates, Fort Myers, FL; K. Scott Coffield, Scott and White Memorial Hospital, Temple, TX; Barrett Cowan, Urology Associates, Denver, CO; Eugene Dula, West Coast Clinical Research, Tarzana, CA; Robert Edelman, Urological Surgeons of Long Island, Garden City, NY; Robert Evans III, The Urology Center, Greensboro, NC; Jeffrey Frankel, Office of Jeffrey Frankel, Seattle, WA; John Freeman, Nevada Urology Associates, Reno, NV; Marc Gittelman, South Florida Medical Research, Aventura, FL; Evan Goldfischer, Hudson Valley Urology, Poughkeepsie, NY; Richard Harris, RMD Clinical Research Institution, Melrose Park, IL; Sean Heron, Pinellas Urology Inc., St. Petersburg, FL; Godfrey Jansz, Burlington Professional Center, Burlington, ON; Gary Karlin, Lawrenceville Urology, Lawrenceville, NJ; Thomas Kinahan, Southern Interior Medical Research Corp., Kelowna, BC; Ira Klimberg, The Urology Center of Florida Inc., Ocala, FL; Wilson Leung, Brantford Urology Research, Brantford, ON; James Lugg, Wyoming Research Foundation, Cheyenne, WY; James McMurtry, Virginia Urology Center, Richmond, VA; David Oselinsky, State College Urological Association, State College, PA; Bruce Palmer, Bruce W. Palmer Urology Inc., Kentville, NS; Thomas Palmer, Regional Urology, Shreveport, LA; Walter Pittman, Urology Centers of Alabama, Homewood, AL; Mark Plante, University of Vermont, South Burlington, VT; Peter Pommerville, University of British Columbia, Victoria, BC; Daniel Saltzstein, Urology San Antonio Research, San Antonio, TX; Alfred Sidhom, Advanced Urology Medical Center, Anaheim, CA; Christopher Steidle, Northeast Indiana Research, Fort Wayne, IN; Barry Stein, University Urological Research Institute, Providence, RI; Gary Steinhoff, Dr. Gary Steinhoff Clinical Research, Victoria, BC; Kevin Tomera, Alaska Clinical Research Center, Anchorage, AK; Jay Young, South Orange County Medical Research Center, Laguna Woods, CA; Joseph Zadra, The Male and Female Health and Research Centers, Barrie, ON; and Norman Zinner, Western Clinical Research, Torrance, CA.MetricsAuthor Information Marc Gittelman Department of Urology, South Florida Medical Research, Aventura, Florida More articles by this author Peter J. Pommerville Department of Urological Sciences, University of British Columbia, Victoria, British Columbia More articles by this author Bo-Eric Persson Department of Global Marketing, Ferring Pharmaceuticals A/S, Copenhagen, Denmark Financial interest and/or other relationship with Ferring Pharmaceuticals A/S. More articles by this author Jens-Kristian Jensen Clinical R&D, Ferring Pharmaceuticals A/S, Copenhagen, Denmark Financial interest and/or other relationship with Ferring Pharmaceuticals A/S. More articles by this author Tine Kold Olesen Clinical R&D, Ferring Pharmaceuticals A/S, Copenhagen, Denmark Financial interest and/or other relationship with Ferring Pharmaceuticals A/S. More articles by this author Degarelix Study Group More articles by this author Expand All Advertisement PDF downloadLoading ...