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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02663908
Recruitment Status : Active, not recruiting
First Posted : January 26, 2016
Last Update Posted : April 1, 2020
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Duke Clinical Research Institute
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Drug: Leuprolide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 554 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Degarelix Drug: Degarelix
Other Name: FIRMAGON
Active Comparator: Leuprolide Drug: Leuprolide
Other Name: LUPRON DEPOT


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time from randomization to occurrence of myocardial infarction (fatal, non-fatal) [ Time Frame: Up to 336 days ]
  2. Time from randomization to occurrence of stroke (fatal, non-fatal) [ Time Frame: Up to 336 days ]
  3. Time from randomization to occurrence of unstable angina requiring hospitalization (fatal, non-fatal) [ Time Frame: Up to 336 days ]
  4. Time from randomization to death due to any cause [ Time Frame: Up to 336 days ]
  5. Time from randomization to cardiovascular-related death [ Time Frame: Up to 336 days ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663908


Locations
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Sponsors and Collaborators
Ferring Pharmaceuticals
Memorial Sloan Kettering Cancer Center
Duke Clinical Research Institute
Investigators
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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
More Information
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02663908    
Other Study ID Numbers: 000108
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Cardiovascular Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
 Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents