The Role of Androgen Deprivation Therapy In Cardiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC1) & A Randomized Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICAL PC2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 95
- 主要终点
- Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.
研究概览
简要总结
RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.
详细描述
RADICAL PC describes two prospective studies, one of which is embedded in the other. RADICAL PC1 is a prospective cohort study of men within one year of their first diagnosis of prostate cancer, or treated with Androgen Deprivation Therapy for the first time within 6 months prior to enrollment visit, or to be treated with Androgen Deprivation Therapy for the first time within one month after the enrollment visit. Its goal will be to identify factors associated with the development of cardiovascular disease among men with prostate cancer, with a particular focus on Androgen Deprivation Therapy. RADICAL PC2 is a randomized, controlled trial embedded in RADICAL PC1. RADICAL PC2 will test a systematic approach to modifying cardiovascular and lifestyle risk factors in men within one year of their first diagnosis of prostate cancer, or treated with Androgen Deprivation Therapy for the first time within 6 months prior to enrollment visit, or to be treated with Androgen Deprivation Therapy for the first time within one month after the enrollment visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1. A man with a diagnosis of prostate cancer that is either:
- •new (i.e. the diagnosis was made within 1 year of the enrolment visit) or
- •treated with Androgen Deprivation Therapy for the first time within 6 months prior to the enrolment visit, or
- •to be treated with Androgen Deprivation Therapy for the first time within 1 month after the enrolment visit
排除标准
- •Patients will be excluded if they fulfill any of the following:
- •are unwilling to provide consent or
- •are <45 years of age, or
- •prostate cancer was found incidentally following cystectomy for bladder cancer
- •Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:
- •see a cardiologist every year, or
- •both take a statin and have systolic blood pressure ≤130mmHg
研究组 & 干预措施
Randomized - Control
The control will consist of usual clinical care, which may include a referral to a cardiologist or internist, or the use of treatments included in the intervention as clinically indicated, if part of the treating physician's standard practice.
Randomized - Intervention
The intervention will consist of a systematic cardiovascular and lifestyle risk factor modification strategy, including dietary and exercise advice, advice to quit smoking, and the prescription of open-label statins, ACE-I, and other antihypertensive medications where appropriate.
干预措施: Smoking cessation (Behavioral)
Randomized - Intervention
The intervention will consist of a systematic cardiovascular and lifestyle risk factor modification strategy, including dietary and exercise advice, advice to quit smoking, and the prescription of open-label statins, ACE-I, and other antihypertensive medications where appropriate.
干预措施: Nutrition (Behavioral)
Randomized - Intervention
The intervention will consist of a systematic cardiovascular and lifestyle risk factor modification strategy, including dietary and exercise advice, advice to quit smoking, and the prescription of open-label statins, ACE-I, and other antihypertensive medications where appropriate.
干预措施: Exercise (Behavioral)
Randomized - Intervention
The intervention will consist of a systematic cardiovascular and lifestyle risk factor modification strategy, including dietary and exercise advice, advice to quit smoking, and the prescription of open-label statins, ACE-I, and other antihypertensive medications where appropriate.
干预措施: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) (Drug)
Randomized - Intervention
The intervention will consist of a systematic cardiovascular and lifestyle risk factor modification strategy, including dietary and exercise advice, advice to quit smoking, and the prescription of open-label statins, ACE-I, and other antihypertensive medications where appropriate.
干预措施: ACE inhibitor (Drug)
结局指标
主要结局
Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.
时间窗: 3-5 years
The primary efficacy outcome is the occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure, or arterial revascularization.
Hierarchical composite of cardiovascular death, myocardial infarction, stroke, heart failure, cholesterol control (defined as total cholesterol ≤4mmol/L) and systolic blood pressure control (defined as systolic blood pressure ≤130mmHg).
时间窗: 3-5 years
Hierarchical composite of cardiovascular death, myocardial infarction, stroke, heart failure, cholesterol control (defined as total cholesterol ≤4mmol/L) and systolic blood pressure control (defined as systolic blood pressure ≤130mmHg).
Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure.
时间窗: 3-5 years
Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure.
次要结局
- Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction(3-5 years)
- Secondary Efficacy Outcome - Event Outcome - Heart Failure(3-5 years)
- Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism(3-5 years)
- Secondary Efficacy Outcome - Event Outcome - CV Death(3-5 years)
- Secondary Efficacy Outcome - Composite of Death, MI, Stroke(3-5 years)
- Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.(3-5 years)
- Secondary Efficacy Outcome - Event Outcome - Stroke(3-5 years)
- Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.(3-5 years)