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. 2023 Aug 1;5(5):613–624. doi: 10.1016/j.jaccao.2023.05.011

Table 1.

Characteristics of the Included Studies

First Author Trial Name ClinicalTrials.gov ID Code Study Publication Max Duration Primary Endpoint Antagonist Agonist Antagonist
Sample
Agonist Sample Metastatic Disease (%) Baseline CVD (%) Median Age (y)
Klotz22,23 CS21 NCT00295750 2006-2007 2008 12 Percentage of patients with testosterone level ≤0.5 ng/mL Degarelix Leuprolide 409 201 20.0 32.1 73.0
Anderson24 CS28 NCT00831233 2009-2010 2013 3 Change from baseline in IPSS Degarelix Goserelin 27 13 35.0 NR 70.0
Mason25 CS30 NCT00833248 2009-2011 2013 3 Change from baseline in prostate size Degarelix Goserelin 180 64 Excluded NR 70.7
Axcrona26 CS31 NCT00884273 2009-2011 2012 3 Change from baseline in prostate size Degarelix Goserelin 84 98 29.6 NR 72.0
Shorea CS35A NCT01242748 2009-2011 2015 13-36 Percentage of patients with testosterone level ≤0.5 ng/mL Degarelix Goserelin 565 282 NR NR 71.6
Higano27 CS37 NCT00928434 2009-2012 2015 14 Percentage of patients with PSA level ≤4 ng/mL Degarelix Leuprolide 225 178 Excluded NR 72.0
Ozono28 Ozono NCT01964170 2013-2016 2018 12 Cumulative probability of patients with testosterone level ≤0.5 ng/mL Degarelix Goserelin 117 117 18.8 NR 75.7
Saad29 C27002 NCT02083185 2014-2017 2018 12 Percentage of patients with testosterone level ≤0.5 ng/mL Relugolix Leuprolide 110 24 NR NR 70.9
Margel30 Margel NCT02475057 2015-2019 2019 12 Endothelial function Degarelix Any 41 39 26.3 100 71.5
Shore5 HERO NCT03085095 2017-2020 2020 12 Cumulative probability of testosterone level ≤0.5 ng/mL Relugolix Leuprolide 622 308 31.7 13.9 71.0
Lopes9 PRONOUNCE NCT02663908 2016-2021 2021 12 Time to first occurrence of adjudicated MACE (all-cause death, MI, or stroke) Degarelix Leuprolide 275 269 20.4 100 73.0

CVD = cardiovascular disease; HERO = A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer; IPSS = International Prostate Symptom Score; MACE = major adverse cardiovascular event; MI = myocardial infarction; NR = not reported; PRONOUNCE = A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease.

a

Data abstracted from www.clinicaltrials.gov.