Does Androgen Suppression Treatment In Prostate Cancer Reduce Myocardial Blood Flow Reserve?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- myocardial flow reserve
研究概览
简要总结
Suppression of effects of androgens with male sex hormones, androgen suppression treatment (AST), has been known to reduce deaths and prolong life in advanced prostate cancer. There have, however, been concerns raised in previous studies that androgen suppression may be associated with increased rate of heart attacks, particularly in older men. This study looks at prostate cancer patients in The Ottawa Hospital Cancer Clinic to see if treating these patients with androgen suppression is associated with a decrease in blood flow to the heart muscles by using Positron Emission Tomography (PET) and brachial artery ultrasound.
详细描述
Treatment group: Prior to the initiation of AST, subjects will have a baseline N-13-ammonia PET scan and a brachial artery ultrasound at the University of Ottawa Heart Institute. Blood glucose and a lipid profile will be obtained. These tests will be repeated 6 - 9 months after starting AST.
Cancer control group: The same testing and intervals will be performed. Normals control group: Baseline testing will be done to establish a normal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Cancer Population:
- •Diagnosis of prostate cancer
- •Treatment group: Scheduled to start AST, at Ottawa Hospital under the care of Radiation Oncology, Urology or Medical Oncology.
- •Control group: no AST scheduled as a treatment option for prostate cancer.
- •Non-Cancer Control Group
- •Male with low pre-test likelihood of coronary artery disease
- •No previous history of cancer.
排除标准
- •Known coronary disease including any of previous revascularization, history of myocardial infarction, coronary disease with >= 50% stenosis in a major coronary vessel on previous angiography, evidence of previous myocardial infarction on 12-lead electrocardiogram, positive myocardial perfusion scan, previous cardiac PET scan, stress echocardiogram or exercise stress test.
- •Subjects with a Summed Stress Score of >4 attributed to coronary disease on baseline PET images
- •Patients previously treated with AST
- •Patients with a life expectancy of less than 1 year.
结局指标
主要结局
myocardial flow reserve
时间窗: 6 - 9 months
The change in global absolute MFR between baseline and follow up PET studies, at a patient level. MFR is defined as the ratio between regional blood flow with maximum vasodilation and baseline regional blood flow.
次要结局
- Regional myocardial perfusion(6 - 9 months)
研究者
Terrence Ruddy
Principal Investigator
Ottawa Heart Institute Research Corporation