A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
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 subjects with prostate cancer and cardiovascular disease.
Timeline
- Start
- 2016-04-19
- Primary completion
- 2021-03-29
- Completion
- 2021-03-29
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
Stopped (Enrollment): “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.”
registry p = 0.5294; Hazard Ratio (HR) 1.283 (95% CI 0.589 to 2.794) NCT02663908 ↗
Publications
- Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sorensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30.
- Melloni C, Slovin SF, Blemings A, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Zubovskiy K, Olesen TK, Dugi K, Clarke NW, Higano CS, Roe MT; PRONOUNCE Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design. JACC CardioOncol. 2020 Mar 17;2(1):70-81. doi: 10.1016/j.jaccao.2020.01.004. eCollection 2020 Mar.
- Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Degarelix | Other / unclassified | — | — |
| Comparator | Leuprolide | Other / unclassified | — | — |