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)

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix; Drug: Leuprolide

• Study Type: Interventional
• Enrollment (Actual): 545
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada
    • CHU de Québec -Hôtel-Dieu de Québec
  • Ontario
    • Barrie, Ontario, Canada
      • The Male Health Centre Euroscope Inc
    • Brampton, Ontario, Canada
      • J. Giddens Medicine Professional Corporation
    • Burlington, Ontario, Canada
      • G. Kenneth Jansz Medicine Professional Corporation
    • Kitchener, Ontario, Canada
      • Urology Associates Urologic Medical Research
    • London, Ontario, Canada
      • London Health Sciences Centre
    • Oakville, Ontario, Canada
      • Femalemale Health Centres
    • Toronto, Ontario, Canada
      • Princess Margaret Cancer Centre
  • Quebec
    • Laval, Quebec, Canada
      • Uro Laval
    • Montréal, Quebec, Canada
      • Jewish General Hospital / McGill University
• Czechia
  • Olomouc, Czechia
    • Fakultni nemocnice Olomouc
  • Ostrava, Czechia
    • Fakultni nemocnice Ostrava
  • Pardubice, Czechia
    • Multiscan s.r.o.
  • Plzen, Czechia
    • Urocentrum Plzen
  • Praha, Czechia
    • Fakultni nemocnice v Motole
  • Praha, Czechia
    • Proton Therapy Center Czech s.r.o.
  • Příbram, Czechia
    • Oblastni nemocnice Pribram a.s.
  • Ústí Nad Labem, Czechia
    • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
• Finland
  • Jyväskylä, Finland
    • Keski-Suomen Keskussairaala
  • Tampere, Finland
    • Tampereen yliopistollinen
• France
  • Avignon, France
    • Institut Sainte Catherine
  • Bordeaux, France
    • Groupe Hospitalier Pellegrin Tripode
  • Créteil, France
    • Hôpital Henri Mondor
  • Grenoble, France
    • CHU de Grenoble - Hopital Albert Michallon
  • Libourne, France
    • CH de Libourne- Hopital Robert Boulin
  • Lille, France
    • Hopital Claude Huriez - CHU Lille
  • Lyon, France
    • Hopital Edouard Herriot - CHU Lyon
  • Nantes, France
    • Centre Hospitalier Regional Universitaire De Tours
  • Paris, France
    • Hôpital Bichat - Claude Bernard
  • Toulouse, France
    • Clinique Saint Jean Languedoc
• Germany
  • Bonn, Germany
    • Gynaekologisches Zentrum Bonn-Friedensplatz
  • Baden Wuerttemberg
    • Freiburg, Baden Wuerttemberg, Germany
      • Universitaetsklinikum Freiburg
    • Kirchheim Unter Teck, Baden Wuerttemberg, Germany
      • Urologische Gemeinschaftspraxis
  • Bayern
    • Herzogenaurach, Bayern, Germany
      • Urologische Gemeinschaftspraxis
  • Niedersachsen
    • Braunschweig, Niedersachsen, Germany
      • Staedtisches Klinikum Braunschweig GmbH - Standort Salzdahlumer
    • Oldenburg, Niedersachsen, Germany
      • Klinikum Oldenburg gGmbH
  • Nordrhein Westfalen
    • Moenchengladbach, Nordrhein Westfalen, Germany
      • Kliniken Maria Hilf GmbH
    • Mülheim, Nordrhein Westfalen, Germany
      • Praxisklinik Urologie Rhein Ruhr
  • Sachsen
    • Dresden, Sachsen, Germany
      • Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
    • Leipzig, Sachsen, Germany
      • Urologie am Nordplatz
  • Sachsen Anhalt
    • Halle, Sachsen Anhalt, Germany
      • Krankenhaus Martha-Maria Halle-Doelau
    • Lutherstadt Eisleben, Sachsen Anhalt, Germany
      • Facharztpraxis für Urologie
• Greece
  • Athens, Greece
    • Central Clinic of Athens
  • Athens, Greece
    • General Hospital of Athens "Alexandra"
  • Athens, Greece
    • T.Y.P.E.T. Hygeias Melathron Hospital
  • Heraklion, Greece
    • University General Hospital of Heraklion
  • Patras, Greece
    • University of Patras Medical School
  • Thessaloníki, Greece
    • General Hospital Papageorgiou
• Poland
  • Kielce, Poland
    • Swietokrzyskie Centrum Onkologii
  • Piotrków Trybunalski, Poland
    • Provita Profamilia
  • Wrocław, Poland
    • WroMedica
  • Łódź, Poland
    • DERMED Centrum Medyczne Sp. z o.o.
• Russian Federation
  • Ekaterinburg, Russian Federation
    • SBHI of Sverdiovsk Region "Sverdiovsk Regional Clinical Hospital #1
  • Moscow, 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"
  • Nizhniy Novgorod, Russian Federation
    • FBHI Privolzhskiy District Medical Centre FMBA of Russia
  • Novosibirsk, Russian Federation
    • Medical Center Avitsenna
  • Omsk, Russian Federation
    • BHI of Omsk region "Clinical Oncology Dispensary
  • Saint-Petersburg, Russian Federation
    • FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"
• Slovakia
  • Bratislava, Slovakia
    • CUIMED s.r.o.
  • Bratislava, Slovakia
    • Urocentrum Bratislava s.r.o.
  • Kosice, Slovakia
    • Vychodoslovensky onkologicky ustav, a.s.
  • Košice, Slovakia
    • Nemocnica Kosice-Saca, a.s.
  • Košice, Slovakia
    • Zeleznicna nemocnica Kosice
  • Levice, Slovakia
    • UROCENTRUM LEVICE s.r.o.
  • Liptovský Mikuláš, Slovakia
    • UROAMB s.r.o.
  • Martin, Slovakia
    • Univerzitna Nemocnica Martin
  • Nitra, Slovakia
    • Fakultna nemocnica Nitra
  • Nitra, Slovakia
    • UROEXAM, spol. s r.o.
  • Prešov, Slovakia
    • MILAB s.r.o.
  • Rimavska Sobota, Slovakia
    • MIRAMED s.r.o
  • Sala, Slovakia
    • UROCENTRUM SALA s.r.o.
  • Trenčín, Slovakia
    • Privátna urologická ambulancia
  • Žilina, Slovakia
    • Fakultna nemocnica s poliklinikou Zilina
• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • Groote Schuur Hospital Department of Urology
• United Kingdom
  • Cambridge, United Kingdom
    • Addenbrooke's Hospital
  • Exeter, United Kingdom
    • Royal Devon and Exeter Hospital (Wonford)
  • Salford, United Kingdom
    • Salford Royal
  • Carmarthenshire
    • Llanelli, Carmarthenshire, United Kingdom
      • Prince Philip Hospital
  • Greater London
    • London, Greater London, United Kingdom
      • Charing Cross Hospital
  • Lincolnshire
    • Scunthorpe, Lincolnshire, United Kingdom
      • Scunthorpe General Hospital
  • Surrey
    • Chertsey, Surrey, United Kingdom
      • St Peter's Hospital
  • West Midlands
    • Sheffield, West Midlands, United Kingdom
      • Royal Hallamshire Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Urology Center of Alabama PC
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Institute of Urology
    • Tucson, Arizona, United States, 85715
      • Urological Associates of Southern Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona College of Medicine
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Urology Associates, PA
  • California
    • Anaheim, California, United States, 92801
      • Pacific Cancer Medical Center, Inc.
    • La Mesa, California, United States, 91942
      • San Diego Clinical Trials
    • Lincoln, California, United States, 95648
      • Clinical Trials Research
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center
    • Torrance, California, United States, 90505
      • Skyline Urology
    • Whittier, California, United States, 90603
      • Innovative Clinical Research Institute
  • Colorado
    • Denver, Colorado, United States, 80211
      • Urology Center of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Urologic Surgeons of Washington
  • Florida
    • Miami, Florida, United States, 33014
      • San Marcus Research Clinic Inc
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center Of Florida
    • Tampa, Florida, United States, 33615
      • Florida Urology Partners
  • Illinois
    • Lake Barrington, Illinois, United States, 60010
      • Comprehensive Urologic Care
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic LLP
  • Indiana
    • Greenwood, Indiana, United States, 46032
      • Urology of Indiana LLC
    • Jeffersonville, Indiana, United States, 47130
      • First Urology PSC
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Clinic
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Research Institute, Inc.
    • Lenexa, Kansas, United States, 66214
      • Kansas City Urology Care
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Maryland
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Associates, P.A.
  • New Jersey
    • Mount Laurel, New Jersey, United States, 08054
      • Delaware Valley Urology LLC Westhampton
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Urology Group of New Mexico PC
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center Prime
    • Elmont, New York, United States, 11003
      • Advanced Urology Centers of New York Elmont Division
    • Syracuse, New York, United States, 13210
      • Suny Upstate Medical University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Salisbury, North Carolina, United States, 28144
      • Veterans Affairs Medical Center-Salisbury, NC
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Signal Point Clinical Research Center
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions PC
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of Southeaster PA LLP
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster Urology
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Ralph H. Johnson VA Medical Center
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System
  • Virginia
    • Norfolk, Virginia, United States, 23462
      • Urology of Virginia
  • Washington
    • Burien, Washington, United States, 98166
      • Seattle Urology Research Center
    • Seattle, Washington, United States, 98195
      • University of Washington School of Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Degarelix	Drug: Degarelix; Other Names: FIRMAGON
Active Comparator: Leuprolide	Drug: Leuprolide; Other Names: LUPRON DEPOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) occurrence of CV-related death, non-fatal myocardial infarction or non-fatal stroke. 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)
Time From Randomization to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) CV-related death. Percentage of observed subjects with outcome measure events during the trial are reported. 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)
Time From Randomization to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) myocardial infarction. 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)
Time From Randomization to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) stroke. 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)
Time From Randomization to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalization; Percentage of Observed Subjects With Outcome Measure Events During the Trial	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) unstable angina requiring hospitalization. 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)
Time From Randomization to Death Due to Any Cause; Percentage of Observed Subjects With Outcome Measure Events During the Trial	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict death due to any cause. 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)
Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide Treatment Groups	Median levels and interquartile ranges for serum testosterone at Days 28, 168, and 336 are presented.	Days 28, 168 and 336 (end-of-trial)
Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial	Time to failure in PFS was defined as the time, measured in days, from randomization to the first occurrence of either death, radiographic disease progression, introduction of additional prostate cancer therapies for progression, or PSA failure. Subjects who discontinued treatment with IMP or withdrew from the trial were censored at the time of discontinuation/withdrawal. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict failure in PFS. Percentage of observed subjects with outcome measure events during the trial are reported.	From randomization to end-of-trial for each subject (subjects not censored at Day 336)
Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores	Lower urinary tract symptoms were measured with the IPSS Version 1 (IPSS-1). The IPSS is a subject-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question was assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS-1 score was then calculated as summation over the responses for all 7 questions. The total IPSS-1 score was transformed to a scale from 0 (lowest score) to 100 (highest score). Higher scores reflect higher severity of symptoms. The IPSS-1 included an additional single question to assess a subject's QoL in relation to his urinary symptoms; response to this question was analyzed separately and was not included in the total IPSS score. The score was similarly scaled from 0 to 100. Change from baseline in IPSS Total and QoL scores are presented.	Baseline to Days 168 and 336 (end-of-trial)
Total Number of CV-related Hospitalization Events Over the Duration of the Trial	The total number of CV-related hospitalizations over the duration of the trial was defined as the number of hospitalizations due to CV-related adverse events, observed from the first exposure to IMP up until Day 336 for each subject.	First dose of IMP to Day 336 (end-of-trial)
Total Number of Coronary Artery By-pass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) Procedures Over the Duration of the Trial	The total number of CABG or PCI procedures observed for each subject over the duration of the trial	First dose of IMP to Day 336 (end-of-trial)
Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial	CV-related ER visit events (that did not lead to hospitalization) was observed from the first exposure to IMP up until Day 336 for each subject.	First dose of IMP to Day 336 (end-of-trial)
Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)	The EQ-5D-5L essentially consists of 2 systems - the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS is an overall estimation of the present health status. The results from the EQ-5D-5L questionnaire were converted into quality adjusted life year (QALY) units. The QALY is estimated by combining the value of life (utility value) and length of life. Quality adjusted life years are based on a principle assuming that a year of life lived in perfect health is worth 1 QALY and that a year of life lived in a state of less than perfect health is worth less than 1.	Baseline to Day 336 (end-of-trial)
Changes From Baseline in Duke Activity Status Index (DASI) Global Score	The DASI is a self-administered instrument developed to measure functional capacity in subjects with cardiovascular disease (CVD). It contains 12 items referring to the present time, assessing the ability to perform physical tasks in five domains: personal care (1 item), ambulation (4 items), household tasks (4 items), sexual function (1 item) and recreation (2 items). Each question was answered by one of four options: 'yes with no difficulty' / 'yes, but with some difficulty' / 'no, I can't do this' / 'don't do this for other reasons'. A global score was calculated with a higher score indicating a higher functional capacity. The minimum score is 0 and the maximum score is 58.2 points. Change from baseline in DASI Global score is presented.	Baseline to Days 168 and 336 (end-of-trial)
Changes From Baseline in Cardiac Anxiety Questionnaire (CAQ) Global Score and Score Per Domain	The CAQ is a self-administered questionnaire developed to measure heart-focused anxiety in persons with or without heart disease. It contains 18 items referring to the present time assessing cardiac anxiety in three domains: fear (8 items, each item could be scored between 0 "never" to 4 "always", maximum total score 32), avoidance (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20) and attention (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20). A higher score indicated greater cardiac anxiety and the total score range was between 0 and 72. Change from baseline in CAQ Global score and score per domain are presented.	Baseline to Days 168 and 336 (end-of-trial)
Number of Subjects With Adverse Events (AEs)	Adverse events were recorded from signed informed consent until end-of-trial. Adverse events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered 'treatment-emergent' and are presented for the safety analysis set.	Start of IMP treatment until 3 months after last dosing of IMP
Intensity of AEs	The intensity of AE was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.02) 5-point scale. AE were categorized as grade 1 Mild (minor; no specific medical intervention; asymptomatic laboratory findings only; marginal clinical relevance), Grade 2 Moderate (minimal intervention: local intervention; non-invasive intervention), Grade 3 Severe (significant symptoms, requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation), Grade 4 Life-threatening or disabling (complicated by acute, life-threatening metabolic or CV complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation) and Grade 5 Death. Events with grades 3, 4 and 5 were categorized as severe.	Start of IMP treatment until 3 months after last dosing of IMP
Changes in Vital Signs	Number of subjects shifting from normal value(s) in vital signs (pulse and blood pressure) at baseline to clinically significant abnormal value(s) at end-of-trial are presented. Note: Only subjects with appropriate baseline and post-baseline data are included in the evaluation.	Baseline to Day 336 (end-of-trial)

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Collaborators: Memorial Sloan Kettering Cancer Center; Duke Clinical Research Institute
• Investigators: 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

Publications and helpful links

General Publications

• 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. Erratum In: Circulation. 2021 Oct 19;144(16):e273.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2016
• Primary Completion (Actual): March 29, 2021
• Study Completion (Actual): March 29, 2021

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Cardiovascular Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: 000108