Table 1.
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.
Data abstracted from www.clinicaltrials.gov.