Study Stopped
Recruitment rate; a lower than anticipated observed cardiovascular event rate. The Sponsor decision to stop the trial was not based on any safety concerns or any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.
A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
PRONOUNCE
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)
1 other identifier
interventional
545
12 countries
133
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Apr 2016
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedStudy Start
First participant enrolled
April 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2021
CompletedResults Posted
Study results publicly available
June 29, 2022
CompletedJune 29, 2022
May 1, 2022
4.9 years
January 22, 2016
March 21, 2022
June 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Composite MACE endpoint was defined as: death due to any cause, non-fatal myocardial infarction or non-fatal stroke. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) occurrence of composite MACE over time. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.
Randomization to Day 336 (end-of-trial)
Secondary Outcomes (18)
Time From Randomization to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction or Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Randomization to Day 336 (end-of-trial)
Time From Randomization to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Randomization to Day 336 (end-of-trial)
Time From Randomization to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Randomization to Day 336 (end-of-trial)
Time From Randomization to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Randomization to Day 336 (end-of-trial)
Time From Randomization to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalization; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Randomization to Day 336 (end-of-trial)
- +13 more secondary outcomes
Study Arms (2)
Degarelix
EXPERIMENTALLeuprolide
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Advanced prostate cancer
- Indication to initiate androgen deprivation therapy (ADT)
- Predefined cardiovascular disease
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Ferring Pharmaceuticalslead
- Memorial Sloan Kettering Cancer Centercollaborator
- Duke Clinical Research Institutecollaborator
Study Sites (133)
Urology Center of Alabama PC
Birmingham, Alabama, 35209, 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
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
University of California, Irvine Medical Center
Orange, California, 92868, 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 D.C., District of Columbia, 20036, United States
San Marcus Research Clinic Inc
Miami, Florida, 33014, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
Florida Urology Partners
Tampa, Florida, 33615, 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
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Associates, P.A.
Towson, Maryland, 21204, 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
Advanced Urology Centers of New York Elmont Division
Elmont, New York, 11003, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center PRIME
The Bronx, New York, 10461, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Veterans Affairs Medical Center-Salisbury, NC
Salisbury, North Carolina, 28144, United States
Signal Point Clinical Research Center
Dayton, Ohio, 45409, United States
Clinical Research Solutions PC
Middleburg Heights, Ohio, 44130, 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 of Virginia
Norfolk, Virginia, 23462, United States
Seattle Urology Research Center
Burien, Washington, 98166, United States
University of Washington School of Medicine
Seattle, Washington, 98195, United States
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226, 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
Related Publications (3)
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.
PMID: 34459214DERIVEDMelloni 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.
PMID: 34396210DERIVEDZengerling 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.
PMID: 34350976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The trial was terminated prematurely due to a slower than anticipated recruitment rate and a lower than anticipated observed CV event rate. Approximately 900 patients were planned to be included, however, at the time of stopping screening and recruitment 216 patients had completed the trial, 292 were ongoing, and 37 were withdrawn. The Sponsor decision to stop the trial was not based on any safety concerns, any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.
Results Point of Contact
- Title
- Global Clinical Compliance
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
- PRINCIPAL INVESTIGATOR
Susan Slovin, MD
Sidney Kimmel Center for Urologic and Prostate Cancers, Memorial Sloan Kettering Cancer Center
- PRINCIPAL INVESTIGATOR
John Alexander, MD, MHS
Division of Cardiovascular Medicine, Duke Clinical Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2016
First Posted
January 26, 2016
Study Start
April 19, 2016
Primary Completion
March 29, 2021
Study Completion
March 29, 2021
Last Updated
June 29, 2022
Results First Posted
June 29, 2022
Record last verified: 2022-05