Trial reportCirculation2021
Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial.
Trial report in Circulation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 85 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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)
To Investigate the Effect of Multidisciplinary Care Approach on Cardiovascular Risk Modification in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Who cites it
85 citing papers in PubMed, 2 syntheses or guidelines pooled it, 142 citations in OpenAlex.
- A systematic review and meta-analysis of cardiovascular disease risk with degarelix and GnRH agonists in prostate cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Pooled it
- Adverse cardiovascular effect following gonadotropin-releasing hormone antagonist versus GnRH agonist for prostate cancer treatment: A systematic review and meta-analysis.Frontiers in endocrinology · 2023Pooled it
- Cardiovascular Mortality and Duration of Androgen Deprivation in Locally Advanced Prostate Cancer: Long-term Update of NRG/RTOG 9202.European urology focus · 2024Trial
- Impact of Concomitant Cardiovascular Therapies on Efficacy and Safety of Relugolix vs Leuprolide: Subgroup Analysis from HERO Study in Advanced Prostate Cancer.Advances in therapy · 2023Trial
- Stratifying Cardiovascular Risk in Patients With HCC Receiving Atezolizumab/Bevacizumab: A Comparison of ESC and CARDIOSOR Scores.Liver international : official journal of the International Association for the Study of the Liver · 2026Observational
- Nonprostate Cancer Deaths Best Predict Long-Term Survival in Men Aged ≤59 Years Treated With Low Dose Rate Brachytherapy With or Without Supplemental Therapies: A Mandate for Health Enhancement.Advances in radiation oncology · 2026Article
- Cardiovascular Complications Associated with Uro-Oncology Treatments-A Primer for the Clinician.Diagnostics (Basel, Switzerland) · 2026Review
- Disproportionality analysis of adverse events associated with degarelix: a real-world study from the FDA Adverse Event Reporting System (FAERS) database.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Do Platelets Explain Why GnRH Antagonists Are Potentially Safer From a Cardiovascular Perspective?JACC. CardioOncology · 2026Article
- Survivorship Challenges in Metastatic Prostate Cancer in the Era of Prolonged Survival: A Review.Cancers · 2026Review
- Multimodality imaging in the detection and management of coronary and peripheral arterial disease in patients with cancer receiving cardiotoxic antineoplastic treatments: A clinical consensus statement of the ESC Council of Cardio-Oncology and the European Association of Cardiovascular Imaging (EACVI) of the ESC.European heart journal. Cardiovascular Imaging · 2026Review
- Oral relugolix for the treatment of advanced prostate cancer.The oncologist · 2026Article
- Personalized intensification of treatment for hormone-sensitive prostate cancer.Nature reviews. Clinical oncology · 2026Review
- Indian Delphi consensus on cardiovascular risk mitigation in prostate cancer management.Frontiers in oncology · 2026Review
- Associations of SGLT2i with Cardiorenal Outcomes Among Diabetics with Prostate Cancer on Hormone Therapy.Cardiovascular drugs and therapy · 2025Observational
- Real-world analyses of major adverse cardiovascular events and mortality risk after androgen deprivation therapy initiation in black vs. white prostate cancer patients.Prostate cancer and prostatic diseases · 2025Article
- Review
- Spinal Cord Infarction Following Zoledronic Acid Administration in a Patient With Metastatic Prostate Cancer.Cureus · 2025Article
- Risk classification for non-cancer death in middle-aged cancer patients.Journal of advanced research · 2025Article
- Outcomes of Novel Hormonal Therapies in Men With Advanced Prostate Cancer by Treating Specialist.Cancer medicine · 2025Article
25 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
19 authors at 11 institutions in 5 countries.
Funding
Abstract
backgroundThe relative cardiovascular safety of gonadotropin-releasing hormone (GnRH) antagonists compared with GnRH agonists in men with prostate cancer and known atherosclerotic cardiovascular disease remains controversial.
methodsIn this international, multicenter, prospective, randomized, open-label trial, men with prostate cancer and concomitant atherosclerotic cardiovascular disease were randomly assigned 1:1 to receive the GnRH antagonist degarelix or the GnRH agonist leuprolide for 12 months. The primary outcome was the time to first adjudicated major adverse cardiovascular event (composite of death, myocardial infarction, or stroke) through 12 months.
resultsBecause of slower-than-projected enrollment and fewer-than-projected primary outcome events, enrollment was stopped before the 900 planned participants were accrued. From May 3, 2016, to April 16, 2020, a total of 545 patients from 113 sites across 12 countries were randomly selected. Baseline characteristics were balanced between study groups. The median age was 73 years, 49.8% had localized prostate cancer; 26.3% had locally advanced disease, and 20.4% had metastatic disease. A major adverse cardiovascular event occurred in 15 (5.5%) patients assigned to degarelix and 11 (4.1%) patients assigned to leuprolide (hazard ratio, 1.28 [95% CI, 0.59-2.79];
conclusionsPRONOUNCE (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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.