{"entity":{"id":"nct02663908","kind":"trial","name":"A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease","aka":["PRONOUNCE"],"tldr":"A phase 3 trial of Degarelix in Prostate cancer, run by Ferring Pharmaceuticals, recorded as terminated on the registry.","summary":"A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease is a phase 3 interventional study registered as NCT02663908 by Ferring Pharmaceuticals, with 545 participants recorded, started 2016-04-19 and due to reach its primary completion in 2021-03-29. Interventions recorded: Degarelix, Leuprolide. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Degarelix because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02663908","url":"https://clinicaltrials.gov/study/NCT02663908"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["degarelix"],"companies":["ferring"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02663908","phase":"3","setting":"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)","sponsor":"Ferring Pharmaceuticals","participation":[{"nct":"NCT02663908","source":"https://clinicaltrials.gov/study/NCT02663908","fetchedAt":"2026-10-07T16:52:49.296Z","studySha256":"175fe3dee277964df3031a88a9297a305ac6d95f8bf0b33ef566e9ea2026c37b","overallStatus":"TERMINATED","lastUpdatePosted":"2022-06-29","whyStopped":"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.","leadSponsor":"Ferring Pharmaceuticals","collaboratorCount":2,"sex":"MALE","healthyVolunteers":false,"hasEligibility":true,"enrolment":545,"enrolmentType":"ACTUAL","siteCount":133,"recruitingSiteCount":0,"countries":["Canada","Czechia","Finland","France","Germany","Greece","Poland","Russia","Slovakia","South Africa","United Kingdom","United States"]}],"started":"2016-04-19","startedType":"actual","yearReported":2022,"enrolled":545,"enrolledBasis":"registry","outcomes":[{"endpoint":"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","primary":true,"unit":"%","arms":[{"name":"Degarelix 240 mg/80 mg","n":275,"value":5.5,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-06-29), not from a publication"},{"name":"Leuprolide 22.5 mg","n":269,"value":4.1}],"hr":1.283,"ci":[0.589,2.794],"p":"0.5294","source":"https://clinicaltrials.gov/study/NCT02663908?tab=results"},{"endpoint":"Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial","unit":"%","arms":[{"name":"Degarelix 240 mg/80 mg","n":275,"value":8.7,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-06-29), not from a publication"},{"name":"Leuprolide 22.5 mg","n":269,"value":10}],"hr":0.887,"ci":[0.512,1.539],"p":"0.6701","source":"https://clinicaltrials.gov/study/NCT02663908?tab=results"}]},"route":"/trials/nct02663908/","neighbours":{"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"drug":[{"id":"degarelix","kind":"drug","name":"Degarelix","route":"/drugs/degarelix/"}],"company":[{"id":"ferring","kind":"company","name":"Ferring Pharmaceuticals","route":"/companies/ferring/"}]}}