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)


Condition: Prostate Cancer

Intervention:

  • Drug: Degarelix
  • Drug: Leuprolide

Purpose: 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 patients with prostate cancer and cardiovascular disease.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02663908

Sponsor: Ferring Pharmaceuticals

Primary Outcome Measures:

  • Measure: Time from randomization to the first confirmed (adjudicated) occurrence of the composite Major Adverse Cardiovascular Event (MACE) endpoint
  • Time Frame: Up to 336 days
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time from randomization to occurrence of myocardial infarction (fatal, non-fatal)
  • Time Frame: Up to 336 days
  • Safety Issue:
  • Measure: Time from randomization to occurrence of stroke (fatal, non-fatal)
  • Time Frame: Up to 336 days
  • Safety Issue:
  • Measure: Time from randomization to occurrence of unstable angina requiring hospitalization (fatal, non-fatal)
  • Time Frame: Up to 336 days
  • Safety Issue:
  • Measure: Time from randomization to death due to any cause
  • Time Frame: Up to 336 days
  • Safety Issue:
  • Measure: Time from randomization to cardiovascular-related death
  • Time Frame: Up to 336 days
  • Safety Issue:

Estimated Enrollment: 900

Study Start Date: April 2016

Phase: Phase 3

Eligibility:

  • Age: minimum N/A maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Advanced prostate cancer
  • Indication to initiate androgen deprivation therapy (ADT)
  • Predefined cardiovascular disease

Exclusion Criteria:

  • Previous or current hormonal management of prostate cancer (unless terminated at least 12 months prior to trial)
  • Acute cardiovascular disease in the previous 30 days

Contact:

  • Global Clinical Compliance

Locations:

  • Urology Center of Alabama PC
  • Birmingham Alabama 35209 United States
  • Alaska Clinical Research Center
  • Anchorage Alaska 99503 United States
  • Arizona Institute of Urology
  • Tucson Arizona 85704 United States
  • Urological Associates of Southern Arizona
  • Tucson Arizona 85715 United States
  • University of Arizona College of Medicine
  • Tucson Arizona 85724 United States
  • Urology Associates, PA
  • Little Rock Arkansas 72211 United States
  • Pacific Cancer Medical Center, Inc.
  • Anaheim California 92801 United States
  • San Diego Clinical Trials
  • La Mesa California 91942 United States
  • Clinical Trials Research
  • Lincoln California 95648 United States
  • Tower Urology Medical Group
  • Los Angeles California 90048 United States
  • VA Greater Los Angeles Healthcare System
  • Los Angeles California 90073 United States
  • University of California, Irvine Medical Center
  • Orange California 92868 United States
  • Urology Associates of the Central Coast
  • San Luis Obispo California 93401 United States
  • Skyline Urology
  • Torrance California 90505 United States
  • Innovative Clinical Research Institute
  • Whittier California 90603 United States
  • Urology Center of Colorado
  • Denver Colorado 80211 United States
  • Yale University
  • New Haven Connecticut 06519 United States
  • Urologic Surgeons of Washington
  • Washington District of Columbia 20036 United States
  • Mount Sinai Comprehensive Cancer Center
  • Miami Beach Florida 33140 United States
  • San Marcus Research Clinic Inc
  • Miami Florida 33014 United States
  • Clinical Research Center of Florida
  • Pompano Beach Florida 33060 United States
  • Florida Urology Partners
  • Tampa Florida 33615 United States
  • G. Patsias, M.D., PA
  • Wellington Florida 33449 United States
  • Comprehensive Urologic Care
  • Lake Barrington Illinois 60010 United States
  • Springfield Clinic LLP
  • Springfield Illinois 62703 United States
  • Urology of Indiana LLC
  • Greenwood Indiana 46032 United States
  • First Urology PSC
  • Jeffersonville Indiana 47130 United States
  • Iowa Clinic
  • West Des Moines Iowa 50266 United States
  • University of Kansas Medical Center Research Institute, Inc.
  • Kansas City Kansas 66160 United States
  • Kansas City Urology Care
  • Lenexa Kansas 66214 United States
  • Tulane University Health Sciences Center
  • New Orleans Louisiana 70121 United States
  • Regional Urology, LLC
  • Shreveport Louisiana 71106 United States
  • Mid-Atlantic Permanente Research Institute
  • Largo Maryland 20774 United States
  • Chesapeake Urology Associates, P.A.
  • Towson Maryland 21204 United States
  • Michigan Institute of Urology
  • Troy Michigan 48081 United States
  • Kansas City VA Medical Center
  • Kansas City Missouri 64128 United States
  • Premier Urology Associates LLC
  • Lawrenceville New Jersey 08648 United States
  • Delaware Valley Urology LLC Westhampton
  • Mount Laurel New Jersey 08054 United States
  • Holy Name Medical Center
  • Teaneck New Jersey 07666 United States
  • Urology Group of New Mexico PC
  • Albuquerque New Mexico 87109 United States
  • Albany Medical College
  • Albany New York 12208 United States
  • Montefiore Medical Center PRIME
  • Bronx New York 10461 United States
  • Advanced Urology Centers of New York Elmont Division
  • Elmont New York 11003 United States
  • Manhattan Medical Research Practice PLLC
  • New York New York 10016 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Premier Medical Group of the Hudson Valley
  • Newburgh New York 12601 United States
  • Premier Medical Group
  • Poughkeepsie New York 12601 United States
  • SUNY Upstate Medical University
  • Syracuse New York 13210 United States
  • Carolina Clinical Trials Inc
  • Concord North Carolina 28025 United States
  • Veterans Affairs Medical Center-Salisbury, NC
  • Salisbury North Carolina 28144 United States
  • PMG Research of Winston-Salem
  • Winston-Salem North Carolina 27103 United States
  • The Carl and Edyth Lindner Center For Research and Education at The Christ Hospital
  • Cincinnati Ohio 45219 United States
  • Signal Point Clinical Research Center
  • Dayton Ohio 45409 United States
  • Clinical Research Solutions PC
  • Middleburg Heights Ohio 44130 United States
  • University of Oklahoma Peggy and Charles Stephenson Cancer Center
  • Oklahoma City Oklahoma 73104 United States
  • Oregon Urology Institute
  • Springfield Oregon 97477 United States
  • Urologic Consultants of Southeaster PA LLP
  • Bala-Cynwyd Pennsylvania 19004 United States
  • Lancaster Urology
  • Lancaster Pennsylvania 17604 United States
  • University of Pennsylvania
  • Philadelphia Pennsylvania 19104 United States
  • Ralph H. Johnson VA Medical Center
  • Charleston South Carolina 29401 United States
  • Medical University of South Carolina (MUSC)
  • Charleston South Carolina 29425 United States
  • Erlanger Health System
  • Chattanooga Tennessee 37403 United States
  • Urology Clinics of North Texas
  • Dallas Texas 75231 United States
  • Urology of Virginia
  • Norfolk Virginia 23462 United States
  • Virginia Urology Center
  • Richmond Virginia 23235 United States
  • Seattle Urology Research Center
  • Burien Washington 98166 United States
  • University of Washington School of Medicine
  • Seattle Washington 98195 United States
  • Madigan Army Medical Center
  • Tacoma Washington 98431 United States
  • Medical College of Wisconsin, Inc.
  • Milwaukee Wisconsin 53226 United States
  • Okanagan Health Surgical Centre
  • Kelowna British Columbia Canada
  • Vancouver Prostate Centre
  • Vancouver British Columbia Canada
  • The Male Health Centre Euroscope Inc
  • Barrie Ontario Canada
  • J. Giddens Medicine Professional Corporation
  • Brampton Ontario Canada
  • St. Joseph's Lifecare Centre
  • Brantford 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
  • 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
  • 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
  • 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
  • Studienpraxis Urologie
  • Nürtingen Germany
  • Athens Medical Center
  • 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
  • FSBI "Moscow scientific research oncology institute"
  • Moscow Russian Federation
  • SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov"
  • Moscow 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
  • Urobet s.r.o.
  • Malacky 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
  • Beatson West of Scotland Cancer Centre
  • Glasgow United Kingdom
  • Salford Royal
  • Salford United Kingdom

View trial on ClinicalTrials.gov