Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment With Quantitative Coronary CT Angiography (CCTA)
Summary
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) .
Detailed description
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.
Arms & interventions
- DeviceCoronary CT Angiography (CCTA)
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
Outcome measures
Primary
Proportion 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
Secondary
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
Time frame: Baseline, 6 months, and 12 months
Eligibility criteria
Study locations (3)
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Methodist Hospital
Indianapolis, Indiana, 46202