Spots Global Cancer Trial Database for A Degarelix Trial in Patients With Prostate Cancer
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Trial Identification
Brief Title: A Degarelix Trial in Patients With Prostate Cancer
Official Title: An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Study ID: NCT01242748
Conditions
Study Description
Brief Summary: A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
Detailed Description: CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920). In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg). It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms). The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of Colorado School of Medicine, Aurora, Colorado, United States
The Urology Center of Colorado, Denver, Colorado, United States
Urology Associates of Dover, PA, Dover, Delaware, United States
South Florida Medical Research, Aventura, Florida, United States
Urology Group of New Mexico, PC, Albuquerque, New Mexico, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology San Antonio Research, Pa, San Antonio, Texas, United States
Seattle Urology Research Center, Burien, Washington, United States
AZ Groeninge - Campus Sint-Maarten, Kortrijk, , Belgium
Jonathan Giddens Medicine Professional Corporation, Brampton, Ontario, Canada
Southern Interior Medical Research Inc., Kelowna, , Canada
Mor Urology, Inc., Newmarket, , Canada
Investigational site, Scarborough, , Canada
Investigational site, Toronto, , Canada
Urocentrum Brno, Brno, , Czech Republic
Nemocnice Jindrichuv Hradec, a.s., Jindrichuv Hradec, , Czech Republic
Kromerizska nemocnice a.s., Kromeriz, , Czech Republic
Fakultni nemocnice v Motole, Praha 5, Praha, , Czech Republic
Vseobecna fakultni nemocnice v Praze, Praha 2, Praha, , Czech Republic
Krajska nemocnice T. Bati a.s., Zlin, , Czech Republic
ODL Terveys Oy, Oulu, , Finland
Pohjois-Karjalan keskussairaala, Tampere, , Finland
Tampereen yliopistollinen sairaala, Tampere, , Finland
Gemeinschaftspraxis Rudolph & Wörner, Kirchheim, , Germany
Urologische Studienpraxis, Nürtingen, , Germany
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház, Budapest, , Hungary
Fövárosi Önkormányzat uzsoki utcai Kórház, Budapest, , Hungary
Semmelweis Egyetem, Budapest, , Hungary
Dombóvári Szent Lukács Egészségügyi Nonprofit Kft., Dombóvár, , Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc, , Hungary
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft, Miskolc, , Hungary
Pécsi Tudományegyetem, Pécs, , Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged, , Hungary
Jávorszky Ödön Kórház, Vác, , Hungary
Hospital Christus Muguerza del Parque, Chihuahua, Chih., , Mexico
Hospital Angeles Culiacan, Culiacan, Sinaloa, , Mexico
Consultorio de Especialidad en Urologia Privado, Durango, , Mexico
Hospital Angeles Lindavista, Mexico City, DF, , Mexico
Médica Sur, S.A.B. de C.V., Mexico City, , Mexico
Consultorio Medico, Zapopan, Jalisco, , Mexico
MC Haaglanden, Den Haag, , Netherlands
Catharina-ziekenhuis, Eindhoven, , Netherlands
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego, Bialystok, , Poland
Centrum Medyczne Medur Sp. z o.o., Bielsko-Biala, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku, Slupsk, , Poland
Private Medical Center SRL, Arad, , Romania
Brasov Emergency Clinical County Hospital, Brasov, , Romania
"Prof. Dr. Th. Burghele" Clinical Hospital, Bucharest, , Romania
"Sfantul Ioan" Emergency Clinical Hospital, Bucharest, , Romania
Dinu Uromedica, Bucharest, , Romania
Fundeni Clinical Institute of Uronephrology and Renal Transplantation, Bucharest, , Romania
PROVITA 2000 Medical Center, Constanta, , Romania
"Dr. C.I. Parhon" Clinical Hospital, Iasi, , Romania
Vita Care Flav Medical Center, Pitesti, , Romania
Sibiu Emergency Clinical County Hospital, Sibiu, , Romania
Dnipropetrovsk State Medical Academy, Dnipropetrovsk, , Ukraine
Donetsk Regional Clinical Territorial Medical Association, Donetsk, , Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval, Kharkiv, , Ukraine
Kyiv City Clinical Hospital #3, Kyiv, , Ukraine
Odesa Regional Clinical Hospital, Odesa, , Ukraine
Municipal Institution "Zaporizhzhia Regional Clinical Hospital", Zaporizhzhya, , Ukraine
Ipswich Hospital, Ipswich, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Clinical Development Support
Affiliation: Ferring Pharmaceuticals
Role: STUDY_DIRECTOR
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