Spots Global Cancer Trial Database for A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
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Trial Identification
Brief Title: A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
Official Title: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)
Study ID: NCT02663908
Conditions
Study Description
Brief Summary: The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease.
Detailed Description:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology Center of Alabama PC, Birmingham, Alabama, United States
Arizona Institute of Urology, Tucson, Arizona, United States
Urological Associates of Southern Arizona, Tucson, Arizona, United States
University of Arizona College of Medicine, Tucson, Arizona, United States
Urology Associates, PA, Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
San Diego Clinical Trials, La Mesa, California, United States
Clinical Trials Research, Lincoln, California, United States
VA Greater Los Angeles Healthcare System, Los Angeles, California, United States
University of California, Irvine Medical Center, Orange, California, United States
Skyline Urology, Torrance, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
Urology Center of Colorado, Denver, Colorado, United States
Yale University, New Haven, Connecticut, United States
Urologic Surgeons of Washington, Washington, District of Columbia, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
San Marcus Research Clinic Inc, Miami, Florida, United States
Clinical Research Center of Florida, Pompano Beach, Florida, United States
Florida Urology Partners, Tampa, Florida, United States
Comprehensive Urologic Care, Lake Barrington, Illinois, United States
Springfield Clinic LLP, Springfield, Illinois, United States
Urology of Indiana LLC, Greenwood, Indiana, United States
First Urology PSC, Jeffersonville, Indiana, United States
Iowa Clinic, West Des Moines, Iowa, United States
University of Kansas Medical Center Research Institute, Inc., Kansas City, Kansas, United States
Kansas City Urology Care, Lenexa, Kansas, United States
Regional Urology, LLC, Shreveport, Louisiana, United States
Chesapeake Urology Associates, P.A., Towson, Maryland, United States
Delaware Valley Urology LLC Westhampton, Mount Laurel, New Jersey, United States
Holy Name Medical Center, Teaneck, New Jersey, United States
Urology Group of New Mexico PC, Albuquerque, New Mexico, United States
Montefiore Medical Center PRIME, Bronx, New York, United States
Advanced Urology Centers of New York Elmont Division, Elmont, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Veterans Affairs Medical Center-Salisbury, NC, Salisbury, North Carolina, United States
Signal Point Clinical Research Center, Dayton, Ohio, United States
Clinical Research Solutions PC, Middleburg Heights, Ohio, United States
Urologic Consultants of Southeaster PA LLP, Bala-Cynwyd, Pennsylvania, United States
Lancaster Urology, Lancaster, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Ralph H. Johnson VA Medical Center, Charleston, South Carolina, United States
Medical University of South Carolina (MUSC), Charleston, South Carolina, United States
Erlanger Health System, Chattanooga, Tennessee, United States
Urology of Virginia, Norfolk, Virginia, United States
Seattle Urology Research Center, Burien, Washington, United States
University of Washington School of Medicine, Seattle, Washington, United States
Medical College of Wisconsin, Inc., Milwaukee, Wisconsin, United States
The Male Health Centre Euroscope Inc, Barrie, Ontario, Canada
J. Giddens Medicine Professional Corporation, Brampton, Ontario, Canada
G. Kenneth Jansz Medicine Professional Corporation, Burlington, Ontario, Canada
Urology Associates Urologic Medical Research, Kitchener, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Femalemale Health Centres, Oakville, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Uro Laval, Laval, Quebec, Canada
Jewish General Hospital / McGill University, Montréal, Quebec, Canada
CHU de Québec -Hôtel-Dieu de Québec, Québec, , Canada
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Multiscan s.r.o., Pardubice, , Czechia
Urocentrum Plzen, Plzen, , Czechia
Fakultni nemocnice v Motole, Praha, , Czechia
Proton Therapy Center Czech s.r.o., Praha, , Czechia
Oblastni nemocnice Pribram a.s., Příbram, , Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z., Ústí Nad Labem, , Czechia
Keski-Suomen keskussairaala, Jyväskylä, , Finland
Tampereen yliopistollinen, Tampere, , Finland
Institut Sainte Catherine, Avignon, , France
Groupe Hospitalier Pellegrin Tripode, Bordeaux, , France
Hôpital Henri Mondor, Créteil, , France
CHU de Grenoble - Hôpital Albert Michallon, Grenoble, , France
CH de Libourne- Hopital Robert Boulin, Libourne, , France
Hopital Claude Huriez - CHU Lille, Lille, , France
Hopital Edouard Herriot - CHU Lyon, Lyon, , France
Centre Hospitalier Régional Universitaire de Tours, Nantes, , France
Hopital Bichat - Claude Bernard, Paris, , France
Clinique Saint Jean Languedoc, Toulouse, , France
Universitaetsklinikum Freiburg, Freiburg, Baden Wuerttemberg, Germany
Urologische Gemeinschaftspraxis, Kirchheim Unter Teck, Baden Wuerttemberg, Germany
Urologische Gemeinschaftspraxis, Herzogenaurach, Bayern, Germany
Staedtisches Klinikum Braunschweig GmbH - Standort Salzdahlumer, Braunschweig, Niedersachsen, Germany
Klinikum Oldenburg gGmbH, Oldenburg, Niedersachsen, Germany
Kliniken Maria Hilf GmbH, Moenchengladbach, Nordrhein Westfalen, Germany
Praxisklinik Urologie Rhein Ruhr, Mülheim, Nordrhein Westfalen, Germany
Krankenhaus Martha-Maria Halle-Doelau, Halle, Sachsen Anhalt, Germany
Facharztpraxis für Urologie, Lutherstadt Eisleben, Sachsen Anhalt, Germany
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt, Dresden, Sachsen, Germany
Urologie am Nordplatz, Leipzig, Sachsen, Germany
Gynaekologisches Zentrum Bonn-Friedensplatz, Bonn, , Germany
Central Clinic of Athens, Athens, , Greece
General Hospital of Athens "Alexandra", Athens, , Greece
T.Y.P.E.T. Hygeias Melathron Hospital, Athens, , Greece
University General Hospital of Heraklion, Heraklion, , Greece
University of Patras Medical School, Patras, , Greece
General Hospital Papageorgiou, Thessaloníki, , Greece
Swietokrzyskie Centrum Onkologii, Kielce, , Poland
Provita Profamilia, Piotrków Trybunalski, , Poland
WroMedica, Wrocław, , Poland
DERMED Centrum Medyczne Sp. z o.o., Łódź, , Poland
SBHI of Sverdiovsk Region "Sverdiovsk Regional Clinical Hospital #1, Ekaterinburg, , Russian Federation
City Clinical Hospital n.a. Botkin, Moscow, , Russian Federation
FSBI "Moscow scientific research oncology institute", Moscow, , Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, , Russian Federation
SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov", Moscow, , Russian Federation
FBHI Privolzhskiy District Medical Centre FMBA of Russia, Nizhniy Novgorod, , Russian Federation
Medical Center Avitsenna, Novosibirsk, , Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary, Omsk, , Russian Federation
FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine", Saint-Petersburg, , Russian Federation
CUIMED s.r.o., Bratislava, , Slovakia
Urocentrum Bratislava s.r.o., Bratislava, , Slovakia
Vychodoslovensky onkologicky ustav, a.s., Kosice, , Slovakia
Nemocnica Kosice-Saca, a.s., Košice, , Slovakia
Zeleznicna nemocnica Kosice, Košice, , Slovakia
UROCENTRUM LEVICE s.r.o., Levice, , Slovakia
UROAMB s.r.o., Liptovský Mikuláš, , Slovakia
Univerzitna nemocnica Martin, Martin, , Slovakia
Fakultna nemocnica Nitra, Nitra, , Slovakia
UROEXAM, spol. s r.o., Nitra, , Slovakia
MILAB s.r.o., Prešov, , Slovakia
MIRAMED s.r.o, Rimavska Sobota, , Slovakia
UROCENTRUM SALA s.r.o., Sala, , Slovakia
Privatna Urologicka ambulancia, Trenčín, , Slovakia
Fakultna nemocnica s poliklinikou Zilina, Žilina, , Slovakia
Groote Schuur Hospital Department of Urology, Cape Town, Western Cape, South Africa
Prince Philip Hospital, Llanelli, Carmarthenshire, United Kingdom
Charing Cross Hospital, London, Greater London, United Kingdom
Scunthorpe General Hospital, Scunthorpe, Lincolnshire, United Kingdom
St Peter's Hospital, Chertsey, Surrey, United Kingdom
Royal Hallamshire Hospital, Sheffield, West Midlands, United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
Royal Devon and Exeter Hospital (Wonford), Exeter, , United Kingdom
Salford Royal, Salford, , United Kingdom
Contact Details
Name: Global Clinical Compliance
Affiliation: Ferring Pharmaceuticals
Role: STUDY_DIRECTOR
Name: Susan Slovin, MD
Affiliation: Sidney Kimmel Center for Urologic and Prostate Cancers, Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: John Alexander, MD, MHS
Affiliation: Division of Cardiovascular Medicine, Duke Clinical Research Institute
Role: PRINCIPAL_INVESTIGATOR
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