ArticleJACC. CardioOncology2020
Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design.
Article in JACC. CardioOncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02663908 (A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events), which is not on this map. Cited by 27 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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)
Who cites it
27 citing papers in PubMed, 49 citations in OpenAlex.
- Impact of leuprolide and goserelin on androgen suppression and adverse events in patients with prostate cancer.The Canadian journal of urology · 2026Trial
- Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial.Circulation · 2021Trial
- Spinal Cord Infarction Following Zoledronic Acid Administration in a Patient With Metastatic Prostate Cancer.Cureus · 2025Article
- Taiwan Consensus for the Management of Cardiovascular Risks and Complications in Patients with Prostate Cancer.Acta Cardiologica Sinica · 2025Article
- Cardiovascular Risk in Prostate Cancer:JACC. CardioOncology · 2024Review
- Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials.Clinical trials (London, England) · 2023Article
- Cardiovascular Effects of GnRH Antagonists Compared With Agonists in Prostate Cancer: A Systematic Review.JACC. CardioOncology · 2023Article
- Cardiovascular Impact of Androgen Deprivation Therapy: from Basic Biology to Clinical Practice.Current oncology reports · 2023Review
- Cardiovascular Complications in Patients with Prostate Cancer: Potential Molecular Connections.International journal of molecular sciences · 2023Review
- Androgen-deprivation therapy with leuprolide increases abdominal adiposity without causing cardiac dysfunction in middle-aged male mice: effect of sildenafil.American journal of physiology. Regulatory, integrative and comparative physiology · 2023Article
- Real-World Evidence Prediction of a Phase IV Oncology Trial: Comparative Degarelix vs Leuprolide Safety.JNCI cancer spectrum · 2022Article
- The Increasing Importance of Rigorous Real-World Evidence.JNCI cancer spectrum · 2022Article
- Androgen Deprivation Therapy in High-Risk Localized and Locally Advanced Prostate Cancer.Cancers · 2022Review
- Cardiovascular toxicities of androgen deprivation therapy in Asian men with localized prostate cancer after curative radiotherapy: a registry-based observational study.Cardio-oncology (London, England) · 2022Article
- Assessment and Mitigation of Cardiovascular Risk for Prostate Cancer Patients: A Review of the Evidence.International journal of clinical practice · 2022Review
- Cardiovascular Safety Assessment in Cancer Drug Development.Journal of the American Heart Association · 2021Review
- Role of Cardiac Biomarkers in Cancer Patients.Cancers · 2021Review
- The Effect of Testosterone on Cardiovascular Disease and Cardiovascular Risk Factors in Men: A Review of Clinical and Preclinical Data.CJC open · 2021Review
- Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment.JAMA network open · 2021Article
- Cardiovascular Events in Men with Prostate Cancer Receiving Hormone Therapy: An Analysis of the FDA Adverse Event Reporting System (FAERS).The Journal of urology · 2021Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 11 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis study will compare the incidence of major adverse cardiovascular events (MACEs) with androgen deprivation therapy (ADT) among men with advanced prostate cancer who are being treated with a gonadotropin-releasing hormone (GnRH) antagonist versus a GnRH agonist.
backgroundTreatment of advanced prostate cancer with ADT might increase the risk of subsequent cardiovascular events among men with known atherosclerotic cardiovascular disease (ASCVD), but a recent meta-analysis suggested that this risk might be lower with ADT using a GnRH antagonist versus a GnRH agonist.
methodsPRONOUNCE is a multicenter, prospective, randomized, open, blinded endpoint trial that will enroll approximately 900 patients with advanced prostate cancer and pre-existing ASCVD who will be treated with ADT. Participants will be randomized to receive the GnRH antagonist degarelix or the GnRH agonist leuprolide as ADT for 12 months. The primary endpoint is time from randomization to first confirmed, adjudicated occurrence of a MACE, which is defined as a composite of all-cause death, nonfatal myocardial infarction, or nonfatal stroke through 12 months of ADT treatment. Baseline cardiovascular biomarkers (high-sensitivity C-reactive protein, high-sensitivity troponin T, and N-terminal pro-brain natriuretic peptide), as well as serial inflammatory and immune biomarkers, will be evaluated in exploratory analyses.
resultsAs of October 1, 2019, a total of 364 patients have been enrolled. The mean age is 74 years, 90% are white, 80% have hypertension or dyslipidemia, 30% diabetes mellitus, 40% have had a previous myocardial infarction, and 65% have had previous revascularization. Regarding prostate cancer features at randomization, 48% of the patients had localized disease, 23% had locally advanced disease, and 18% had metastatic disease.
conclusionsPRONOUNCE is the first prospective cardiovascular outcomes trial in advanced prostate cancer that will delineate whether the risk of subsequent cardiovascular events associated with ADT is lower with a GnRH antagonist versus a GnRH agonist for men with pre-existing ASCVD. (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease [PRONOUNCE]; NCT02663908).
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