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March 1, 2020JACC CardioOncologyOpen Access

Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer

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Why the study?

ADT for advanced prostate cancer may increase cardiovascular events in men with pre-existing ASCVD, though a meta-analysis suggested risk might be lower with a GnRH antagonist versus agonist.

Does degarelix reduce MACE compared to leuprolide in men with advanced prostate cancer and pre-existing ASCVD?

Population

Approximately 900 planned (364 enrolled) patients with advanced prostate cancer and pre-existing ASCVD

Comparison

Degarelix vs leuprolide

Design

Multicenter prospective randomized open blinded-endpoint trial

Follow-up

12 months

Authors

CMChiara MelloniSSSusan F. SlovinABAllan Blemings

Discussion

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Overview

Provides first randomized CV safety comparison of GnRH therapies in prostate cancer with ASCVD; extends prior observational data to prospective outcomes.

Structured PICO

Does degarelix reduce MACE compared to leuprolide in men with advanced prostate cancer and pre-existing ASCVD?

P
Population
364 enrolled (target 900) men with advanced prostate cancer and pre-existing atherosclerotic cardiovascular disease (ASCVD), mean age 74 years, 90% white.
I
Intervention
Degarelix (GnRH antagonist) as androgen deprivation therapy for 12 months
C
Comparator
Leuprolide (GnRH agonist) as androgen deprivation therapy for 12 months
O
Outcome
Time from randomization to first confirmed, adjudicated occurrence of a MACE (composite of all-cause death, nonfatal myocardial infarction, or nonfatal stroke) through 12 months of treatmentcomposite

PRONOUNCE is the first prospective cardiovascular outcomes trial designed to compare the cardiovascular safety of a GnRH antagonist versus a GnRH agonist in men with advanced prostate cancer and pre-existing ASCVD.

Cite This Study

Melloni et al. (2020) studied this question.

synapsesocial.com/papers/6a7df835c6a151781133aac3https://doi.org/10.1016/j.jaccao.2020.01.004
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Cardiovascular Morbidity in a Randomized Trial Comparing GnRH Agonist and GnRH Antagonist among Patients with Advanced Prostate Cancer and Preexisting Cardiovascular Disease2019 · 146 citations
  2. 22014 ACC/AHA/AATS/PCNA/SCAI/STS Focused Update of the Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease2014 · 701 citations
  3. 3Androgen Deprivation Therapy for Prostate Cancer2005 · 1,091 citations
  4. 4Competing Causes of Death From a Randomized Trial of Extended Adjuvant Endocrine Therapy for Breast Cancer2008 · 181 citations
  5. 5Prospective Randomized Open Blinded End-point (PROBE) Study. A novel design for intervention trials1992 · 582 citations