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A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease (PRONOUNCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02663908
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Duke Clinical Research Institute
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 22, 2016
First Posted Date  ICMJE January 26, 2016
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE April 2016
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
Time from randomization to the first confirmed (adjudicated) occurrence of the composite Major Adverse Cardiovascular Event (MACE) endpoint [ Time Frame: Up to 336 days ]
Composite MACE endpoint defined as: death due to any cause, non-fatal myocardial infarction or non-fatal stroke
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
Time from randomization to the first confirmed (adjudicated) occurrence of the composite Major Adverse Cardiovascular Event (MACE) endpoint [ Time Frame: Up to 336 days ]
Composite MACE endpoint defined as: death due to any cause, non-fatal myocardial infarction, non-fatal stroke, or non-fatal unstable angina requiring hospitalization
Change History Complete list of historical versions of study NCT02663908 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
  • Time from randomization to occurrence of myocardial infarction (fatal, non-fatal) [ Time Frame: Up to 336 days ]
  • Time from randomization to occurrence of stroke (fatal, non-fatal) [ Time Frame: Up to 336 days ]
  • Time from randomization to occurrence of unstable angina requiring hospitalization (fatal, non-fatal) [ Time Frame: Up to 336 days ]
  • Time from randomization to death due to any cause [ Time Frame: Up to 336 days ]
  • Time from randomization to cardiovascular-related death [ Time Frame: Up to 336 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
Official Title  ICMJE 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)
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 patients with prostate cancer and cardiovascular disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Degarelix
    Other Name: FIRMAGON
  • Drug: Leuprolide
    Other Name: LUPRON DEPOT
Study Arms  ICMJE
  • Experimental: Degarelix
    Intervention: Drug: Degarelix
  • Active Comparator: Leuprolide
    Intervention: Drug: Leuprolide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2016)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Global Clinical Compliance DK0-Disclosure@ferring.com
Listed Location Countries  ICMJE Canada,   Czechia,   Finland,   France,   Germany,   Greece,   Poland,   Russian Federation,   Slovakia,   South Africa,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02663908
Other Study ID Numbers  ICMJE 000108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE
  • Memorial Sloan Kettering Cancer Center
  • Duke Clinical Research Institute
Investigators  ICMJE
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: Matthew Roe, MD, MHS Division of Cardiovascular Medicine, Duke Clinical Research Institute
PRS Account Ferring Pharmaceuticals
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP