A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease (PRONOUNCE)
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| ClinicalTrials.gov Identifier: NCT02663908 |
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Recruitment Status :
Recruiting
First Posted : January 26, 2016
Last Update Posted : November 12, 2018
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Sponsor:
Ferring Pharmaceuticals
Collaborators:
Memorial Sloan Kettering Cancer Center
Duke Clinical Research Institute
Information provided by (Responsible Party):
Ferring Pharmaceuticals
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 900 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 : | December 2020 |
| Estimated Study Completion Date : | December 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: Degarelix |
Drug: Degarelix
Other Name: FIRMAGON |
| Active Comparator: Leuprolide |
Drug: Leuprolide
Other Name: LUPRON DEPOT |
Primary Outcome Measures :
- 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 :
- 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 ]
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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
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
Contacts
| Contact: Global Clinical Compliance | DK0-Disclosure@ferring.com |
Show 86 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Memorial Sloan Kettering Cancer Center
Duke Clinical Research Institute
Investigators
| Study Director: | Global Clinical Compliance | Ferring Pharmaceuticals | |
| Principal Investigator: | Howard Scher, 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 |
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02663908 History of Changes |
| Other Study ID Numbers: |
000108 |
| First Posted: | January 26, 2016 Key Record Dates |
| Last Update Posted: | November 12, 2018 |
| Last Verified: | November 2018 |
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 |