E David Crawford1, Neal D Shore2, Judd W Moul3, Bertrand Tombal4, Fritz H Schröder5, Kurt Miller6, Laurent Boccon-Gibod7, Anders Malmberg8, Tine Kold Olesen8, Bo-Eric Persson9, Laurence Klotz10. 1. Department of Urologic Oncology, School of Medicine, University of Colorado Denver, Aurora, CO. Electronic address: david.crawford@uchsc.edu. 2. Carolina Urologic Research Center, Myrtle Beach, SC. 3. Division of Surgery and Urology, Duke University Medical Center, Durham, NC. 4. Department of Urology, University Clinics Saint Luc/Catholic University of Leuven, Brussels, Belgium. 5. Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands. 6. Department of Urology, Charité University Medicine Berlin, Berlin, Germany. 7. Department of Urology, CHU Hospital Bichat-Claude Bernard, Paris, France. 8. Ferring Pharmaceuticals, Copenhagen, Denmark. 9. Ferring Pharmaceuticals, Saint-Prex, Switzerland. 10. Division of Urology, University of Toronto, Ontario, Canada.
Abstract
OBJECTIVE: To demonstrate the safety and efficacy of up to 5 years of degarelix treatment and the effects of crossing over from leuprolide to degarelix in the extension phase of a phase III pivotal 1-year trial. METHODS:Patients receivingdegarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses. Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65). Safety and tolerability were assessed (primary end point), as well as testosterone and prostate-specific antigen levels and prostate-specific antigen progression-free survival (secondary end points). RESULTS:Adverse event frequency was similar between both the groups. Adverse events included initial injection site reactions, hot flushes, and increased weight. Testosterone and prostate-specific antigen values during the extension study were similar to those seen during the 1-year trial in patients who continued on degarelix or crossed over fromleuprolide. The prostate-specific antigen progression-free survival hazard rate was decreased significantly after the crossover in the leuprolide to degarelix group (from 0.20 to 0.09; P = .002), whereas in patients who continued on degarelix, the rate did not change significantly. In patients with baseline prostate-specific antigen >20 ng/mL, the same hazard rate change pattern was observed on crossover (from 0.38 to 0.19; P = .019). CONCLUSION:Degarelix was well tolerated; no safety concerns were identified. The significant prostate-specific antigen progression-free survival benefit established for degarelix over leuprolide during year 1 remained consistent at 5 years.
RCT Entities:
OBJECTIVE: To demonstrate the safety and efficacy of up to 5 years of degarelix treatment and the effects of crossing over from leuprolide to degarelix in the extension phase of a phase III pivotal 1-year trial. METHODS:Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses. Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65). Safety and tolerability were assessed (primary end point), as well as testosterone and prostate-specific antigen levels and prostate-specific antigen progression-free survival (secondary end points). RESULTS: Adverse event frequency was similar between both the groups. Adverse events included initial injection site reactions, hot flushes, and increased weight. Testosterone and prostate-specific antigen values during the extension study were similar to those seen during the 1-year trial in patients who continued on degarelix or crossed over from leuprolide. The prostate-specific antigen progression-free survival hazard rate was decreased significantly after the crossover in the leuprolide to degarelix group (from 0.20 to 0.09; P = .002), whereas in patients who continued on degarelix, the rate did not change significantly. In patients with baseline prostate-specific antigen >20 ng/mL, the same hazard rate change pattern was observed on crossover (from 0.38 to 0.19; P = .019). CONCLUSION:Degarelix was well tolerated; no safety concerns were identified. The significant prostate-specific antigen progression-free survival benefit established for degarelix over leuprolide during year 1 remained consistent at 5 years.
Authors: Laurence Klotz; Rodney H Breau; Loretta L Collins; Martin E Gleave; Tom Pickles; Frederic Pouliot; Fred Saad Journal: Can Urol Assoc J Date: 2017 Jan-Feb Impact factor: 1.862
Authors: S Gillessen; A Omlin; G Attard; J S de Bono; E Efstathiou; K Fizazi; S Halabi; P S Nelson; O Sartor; M R Smith; H R Soule; H Akaza; T M Beer; H Beltran; A M Chinnaiyan; G Daugaard; I D Davis; M De Santis; C G Drake; R A Eeles; S Fanti; M E Gleave; A Heidenreich; M Hussain; N D James; F E Lecouvet; C J Logothetis; K Mastris; S Nilsson; W K Oh; D Olmos; A R Padhani; C Parker; M A Rubin; J A Schalken; H I Scher; A Sella; N D Shore; E J Small; C N Sternberg; H Suzuki; C J Sweeney; I F Tannock; B Tombal Journal: Ann Oncol Date: 2015-06-03 Impact factor: 32.976