A Pilot Study on Endothelial Function and Cardiovascular Biomarkers in Prostate Cancer (PCa) Patients, With Pre-existing Cardiovascular Disease, Treated With Degarelix vs. Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Reactive Hyperemia Index from baseline to twelve months
研究概览
简要总结
The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists.
详细描述
This is a national multicenter randomized open-label superiority study of the use of Degarelix compared to LHRH agonists among men with advanced prostate cancer and pre-existing cardiovascular disease. Patients will be stratified based on baseline endothelial function and presence prostate cancer metastasis.
Study population: Subjects with pre-existing cardiovascular disease with locally advanced or metastatic prostate cancer and scheduled to start Androgen Deprivation Therapy (ADT). Patients already on ADT will be excluded. subjects will receive either two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months or an LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year. Follow-up visits will occur every 3 months. A blood sample for Prostate-specific antigen (PSA), cardiac biomarkers and rectal examination will be performed each visit. At baseline 6 and 12 months EndoPAT2000 measurements will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with locally advanced or metastatic prostate cancer or high-risk prostate cancer.
- •Scheduled to start ADT for a period of at least one year.
- •Subject has a history of one or more of the following:
- •Myocardial infarction
- •Ischaemic or Haemorrhagic cerebrovascular conditions
- •Arterial embolic and thrombotic events,
- •Ischaemic heart disease
- •Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)
- •Peripheral vascular disease (e.g. significant stenosis (ABPI<0.9), claudication, prior vascular surgery/intervention)
- •Life expectancy of over 12 months.
- •WHO performance status of 0-2
- •Subject is able and has agreed to sign a consent form.
排除标准
- •Prior use of ADT. However, prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat will be allowed.
- •Prior use of dutasteride/finasteride in past 6 months
- •Known allergic reaction to Degarelix.
- •Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
研究组 & 干预措施
Degarelix (LHRH antagonist)
Degarelix (LHRH antagonist) EndoPAT2000
干预措施: Degarelix (LHRH antagonist) (Drug)
Degarelix (LHRH antagonist)
Degarelix (LHRH antagonist) EndoPAT2000
干预措施: EndoPAT2000 (Device)
LHRH agonist
LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000
干预措施: LHRH agonist (Drug)
LHRH agonist
LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000
干预措施: EndoPAT2000 (Device)
结局指标
主要结局
Change in Reactive Hyperemia Index from baseline to twelve months
时间窗: Baseline, and twelve months
the Reactive Hyperemia Index is a measure of endothelial function. It will be measured using the EndoPAT2000
次要结局
- Change in C-reactive protein value(Baseline, and after three, six and twelve months of treatment initiation)
- Change in High sensitivity troponin (hsTn) value(Baseline, and after three, six and twelve months of treatment initiation)
- Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value(Baseline, and after three, six and twelve months of treatment initiation)
- Change in D-dimer value(Baseline, and after three, six and twelve months of treatment initiation)