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) .
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States
RECRUITINGIndiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
RECRUITINGMethodist Hospital
Indianapolis, Indiana, United States
RECRUITINGProportion of Atherosclerosis in CCTA Arm
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
Time frame: Baseline
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin
Time frame: Baseline
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
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.
Time frame: Baseline, 6 months, and 12 months
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