Effect of systematic lifestyle advice & use of cholesterol reducing drugs on cardiovascular disease outcomes among men with newly diagnosed prostate cancer on androgen deprivation therapy.
Phase 3
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2023/07/054807
- Lead Sponsor
- Dr Jehonathan Pinthus Dr Leong Darryl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with diagnosed prostate cancer who are either
a) Newly diagnosed (i.e. the diagnosis was made within 1 year of the enrolment visit), or
b) Treated with ADT for the first time within 6 months prior to the enrolment visit,
or
c) To be treated with ADT for the first time within 1 month after the enrolment visit
Exclusion Criteria
Patients will be excluded if they fulfill any of the following:
a) Are unwilling to provide consent, or
b) Are <45 years of age, or
c) 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:
a) See a cardiologist every year, or
b) Both take a statin and have systolic blood pressure =130mm of Hg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure, or arterial revascularization.Timepoint: 3-5 years
- Secondary Outcome Measures
Name Time Method 1.Occurrence of composite all-cause mortality, myocardial infarction, stroke, or heart failure <br/ ><br>2.Composite of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina, <br/ ><br>3.Cardiovascular death <br/ ><br>4.Myocardial infarction <br/ ><br>5.Stroke <br/ ><br>6.Heart failure <br/ ><br>7.Venous thromboembolism <br/ ><br>Timepoint: 3-5 years