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)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 545
- 试验地点
- 132
- 主要终点
- Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial
研究概览
简要总结
The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Advanced prostate cancer
- •Indication to initiate androgen deprivation therapy (ADT)
- •Predefined cardiovascular disease
排除标准
- •Previous or current hormonal management of prostate cancer (unless terminated at least 12 months prior to trial)
- •Acute cardiovascular disease in the previous 30 days
研究组 & 干预措施
Degarelix
干预措施: Degarelix (Drug)
Leuprolide
干预措施: Leuprolide (Drug)
结局指标
主要结局
Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial
时间窗: Randomization to Day 336 (end-of-trial)
Composite MACE endpoint was defined as: death due to any cause, non-fatal myocardial infarction or non-fatal stroke. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) occurrence of composite MACE over time. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.
次要结局
- Time From Randomization to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial(Randomization to Day 336 (end-of-trial))
- Time From Randomization to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalization; Percentage of Observed Subjects With Outcome Measure Events During the Trial(Randomization to Day 336 (end-of-trial))
- Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores(Baseline to Days 168 and 336 (end-of-trial))
- Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial(From randomization to end-of-trial for each subject (subjects not censored at Day 336))
- Total Number of CV-related Hospitalization Events Over the Duration of the Trial(First dose of IMP to Day 336 (end-of-trial))
- Total Number of Coronary Artery By-pass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) Procedures Over the Duration of the Trial(First dose of IMP to Day 336 (end-of-trial))
- Changes in Vital Signs(Baseline to Day 336 (end-of-trial))
- Time From Randomization to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial(Randomization to Day 336 (end-of-trial))
- Time From Randomization to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial(Randomization to Day 336 (end-of-trial))
- Time From Randomization to Death Due to Any Cause; Percentage of Observed Subjects With Outcome Measure Events During the Trial(Randomization to Day 336 (end-of-trial))
- Time From Randomization to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction or Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial(Randomization to Day 336 (end-of-trial))
- Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial(First dose of IMP to Day 336 (end-of-trial))
- Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide Treatment Groups(Days 28, 168 and 336 (end-of-trial))
- Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)(Baseline to Day 336 (end-of-trial))
- Changes From Baseline in Duke Activity Status Index (DASI) Global Score(Baseline to Days 168 and 336 (end-of-trial))
- Changes From Baseline in Cardiac Anxiety Questionnaire (CAQ) Global Score and Score Per Domain(Baseline to Days 168 and 336 (end-of-trial))
- Number of Subjects With Adverse Events (AEs)(Start of IMP treatment until 3 months after last dosing of IMP)
- Intensity of AEs(Start of IMP treatment until 3 months after last dosing of IMP)