Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial.
Renato Deláscio LopesCelestia S HiganoSusan F SlovinAdam J NelsonRobert BigelowPer S SørensenChiara MelloniShaun G GoodmanChristopher P EvansJan NillsonDeepak L BhattNoel W ClarkeTine Kold OlesenBelinda T Doyle-OlsenHenriette KristensenLauren ArneyMatthew T RoeJohn H Alexandernull nullPublished in: Circulation (2021)
PRONOUNCE (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease) is the first, international, randomized clinical trial to prospectively compare the cardiovascular safety of a GnRH antagonist and a GnRH agonist in patients with prostate cancer. The study was terminated prematurely because of the smaller than planned number of participants and events, and no difference in major adverse cardiovascular events at 1 year between patients assigned to degarelix or leuprolide was observed. The relative cardiovascular safety of GnRH antagonists and agonists remains unresolved. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02663908.
Keyphrases
- prostate cancer
- cardiovascular events
- cardiovascular disease
- radical prostatectomy
- end stage renal disease
- type diabetes
- newly diagnosed
- clinical trial
- ejection fraction
- chronic kidney disease
- prognostic factors
- randomized controlled trial
- metabolic syndrome
- emergency department
- study protocol
- phase iii
- cardiovascular risk factors
- open label
- double blind
- phase ii
- electronic health record