Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment With Quantitative Coronary CT Angiography (CCTA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
研究概览
简要总结
This is a randomized pilot study of Coronary CT Angiography (CCTA) for coronary atherosclerosis vs. Usual Care in patients with prostate cancer who are either planning to begin, or are currently taking androgen deprivation therapy (ADT) .
详细描述
This is a randomized pilot study where subjects are randomized 1:1 to either the CCTA group or non-CCTA (usual care) group. The target enrollment will be 100 subjects with accounting for a potential 10% dropout rate resulting in an sample size between 90-100 participants or 45-50per group arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent and HIPAA authorization for release of personal health information
- •Age ≥40 years at time of consent
- •Previous diagnosis of prostate cancer who are either currently receiving ADT, or who are planning to start ADT for >12 months
- •Patients currently on or planned for treatment with ADT plus androgen pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) are allowed
- •≥1 risk factor for ASCVD (hypertension, hyperlipidemia, diabetes, tobacco use)
- •No current cardiac symptoms
排除标准
- •Concurrent treatment with chemotherapy (docetaxel, cabazitaxel, mitoxantrone) at time of signing consent
- •Patient has implantable cardioverter-defibrillator (ICD), or pacemaker
- •History of coronary stents, obstructive coronary artery disease, myocardial infarction, coronary artery bypass grafting. History of atrial fibrillation
- •Renal dysfunction with creatinine clearance <35ml/min (calculated by Cockcroft-Gault Equation)
- •Allergy to iodinated contrast
- •Contraindication to the medications that may be given to regulate heart rate for the CCTA scan (applicable only to those randomized to the CCTA group)
- •Patients taking sildenafil or tadalafil for vasodilation, pulmonary hypertension, or BPH
- •Note: Subjects taking sildenafil or tadalafil for erectile disfunction will still be eligible.
研究组 & 干预措施
CCTA Group
干预措施: Coronary CT Angiography (CCTA) (Device)
Usual Care Group
结局指标
主要结局
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
时间窗: Baseline
Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin
Proportion of Atherosclerosis in CCTA Arm
时间窗: Baseline
Proportion of prostate cancer patients without cardiac symptoms in the CCTA arm who are reclassified into a higher risk group using automated plaque assessment from CCTA that would otherwise be classed as low risk for ASCVD using the PCE
次要结局
- Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score(Baseline, 6 months, and 12 months)
研究者
Abhishek Khemka
Associate Professor of Clinical Medicine in Division of Cardiovascular Medicine
Indiana University