A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
NCT ID: NCT02663908
Last Updated: 2022-06-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
545 participants
INTERVENTIONAL
2016-04-19
2021-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Degarelix
Degarelix
Leuprolide
Leuprolide
Interventions
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Degarelix
Leuprolide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Indication to initiate androgen deprivation therapy (ADT)
* Predefined cardiovascular disease
Exclusion Criteria
* Acute cardiovascular disease in the previous 30 days
MALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Duke Clinical Research Institute
OTHER
Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Susan Slovin, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Center for Urologic and Prostate Cancers, Memorial Sloan Kettering Cancer Center
John Alexander, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiovascular Medicine, Duke Clinical Research Institute
Locations
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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 D.C., District of Columbia, United States
San Marcus Research Clinic Inc
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, 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
Advanced Urology Centers of New York Elmont Division
Elmont, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center PRIME
The Bronx, 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
Montreal, 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
Pilsen, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Proton Therapy Center Czech s.r.o.
Prague, , 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 im Breisgau, Baden-Wurttemberg, Germany
Urologische Gemeinschaftspraxis
Kirchheim unter Teck, Baden-Wurttemberg, Germany
Urologische Gemeinschaftspraxis
Herzogenaurach, Bavaria, Germany
Staedtisches Klinikum Braunschweig GmbH - Standort Salzdahlumer
Braunschweig, Lower Saxony, Germany
Klinikum Oldenburg gGmbH
Oldenburg, Lower Saxony, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, North Rhine-Westphalia, Germany
Praxisklinik Urologie Rhein Ruhr
Mülheim, North Rhine-Westphalia, Germany
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, Saxony, Germany
Urologie am Nordplatz
Leipzig, Saxony, Germany
Facharztpraxis für Urologie
Eisleben Lutherstadt, Saxony-Anhalt, Germany
Krankenhaus Martha-Maria Halle-Doelau
Halle, Saxony-Anhalt, 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
Pátrai, , Greece
General Hospital Papageorgiou
Thessaloniki, , Greece
Swietokrzyskie Centrum Onkologii
Kielce, , Poland
DERMED Centrum Medyczne Sp. z o.o.
Lodz, , Poland
Provita Profamilia
Piotrkow Trybunalski, , Poland
WroMedica
Wroclaw, , Poland
City Clinical Hospital n.a. Botkin
Moscow, , Russia
FSBI "Moscow scientific research oncology institute"
Moscow, , Russia
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, , Russia
SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov"
Moscow, , Russia
FBHI Privolzhskiy District Medical Centre FMBA of Russia
Nizhny Novgorod, , Russia
Medical Center Avitsenna
Novosibirsk, , Russia
BHI of Omsk region "Clinical Oncology Dispensary
Omsk, , Russia
FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"
Saint Petersburg, , Russia
SBHI of Sverdiovsk Region "Sverdiovsk Regional Clinical Hospital #1
Yekaterinburg, , Russia
CUIMED s.r.o.
Bratislava, , Slovakia
Urocentrum Bratislava s.r.o.
Bratislava, , Slovakia
Nemocnica Kosice-Saca, a.s.
Košice, , Slovakia
Vychodoslovensky onkologicky ustav, 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
Rimavská Sobota, , Slovakia
UROCENTRUM SALA s.r.o.
Šaľa, , 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
Countries
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References
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Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sorensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30.
Melloni C, Slovin SF, Blemings A, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Zubovskiy K, Olesen TK, Dugi K, Clarke NW, Higano CS, Roe MT; PRONOUNCE Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design. JACC CardioOncol. 2020 Mar 17;2(1):70-81. doi: 10.1016/j.jaccao.2020.01.004. eCollection 2020 Mar.
Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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000108
Identifier Type: -
Identifier Source: org_study_id
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