前列腺癌的冠状动脉 CT 血管造影扫描
在斑块评估和定量冠状动脉 CT 血管造影 (CCTA) 指导下对前列腺癌患者冠状动脉粥样硬化进行个性化治疗
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) .
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Elizabeth Rowe
- 电话号码：(317) 278-1185
- 邮箱：rowee@iu.edu
研究联系人备份
- 姓名：Abhishek Khemka, MD
- 电话号码：(317) 962-0500
- 邮箱：akhemka@iu.edu
学习地点
-
-
Indiana
-
Carmel、Indiana、美国、46032
- 招聘中
- IU Health Joe and Shelly Schwarz Cancer Center
-
接触：
- Elizabeth Rowe
- 电话号码：317-278-1185
- 邮箱：rowee@iu.edu
-
首席研究员：
- Abhishek Khemka, MD
-
Indianapolis、Indiana、美国、46202
- 招聘中
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
-
接触：
- Elizabeth Rowe
- 电话号码：317-278-1185
- 邮箱：rowee@iu.edu
-
首席研究员：
- Abhishek Khemka, MD
-
Indianapolis、Indiana、美国、46202
- 招聘中
- Methodist Hospital
-
接触：
- Elizabeth Rowe
- 电话号码：317-278-1185
- 邮箱：rowee@iu.edu
-
首席研究员：
- Abhishek Khemka, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
-
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：日常护理组
|
|
|
实验性的：CCTA集团
|
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Atherosclerosis in CCTA Arm
大体时间：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 and PREVENT. |
Baseline
|
|
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
大体时间：Baseline
|
Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin |
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
大体时间：Baseline, 6 months, and 12 months
|
Changes in risk over time with intensive medical treatment tailored to plaque burden to test results in a reduction in cardiovascular risk factors including blood pressure, glucose and lipid levels, thus reducing the ASCVD risk score. |
Baseline, 6 months, and 12 months
|
合作者和调查者
调查人员
- 首席研究员：Abhishek Khemka, MD、Indiana University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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