ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

Study Overview
=================
Brief 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.

Official Title
-----------------
Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment With Quantitative Coronary CT Angiography (CCTA)

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Coronary CT Angiography (CCTA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent and HIPAA authorization for release of personal health information Age ≥40 years at time of consent Previous diagnosis of prostate cancer who are either currently receiving ADT, or who are planning to start ADT for >12 months Patients currently on or planned for treatment with ADT plus androgen pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) are allowed ≥1 risk factor for ASCVD (hypertension, hyperlipidemia, diabetes, tobacco use) No current cardiac symptoms Exclusion Criteria: Concurrent treatment with chemotherapy (docetaxel, cabazitaxel, mitoxantrone) at time of signing consent Patient has implantable cardioverter-defibrillator (ICD), or pacemaker History of coronary stents, obstructive coronary artery disease, myocardial infarction, coronary artery bypass grafting. History of atrial fibrillation Renal dysfunction with creatinine clearance <35ml/min (calculated by Cockcroft-Gault Equation) Allergy to iodinated contrast Contraindication to the medications that may be given to regulate heart rate for the CCTA scan (applicable only to those randomized to the CCTA group) Patients taking sildenafil or tadalafil for vasodilation, pulmonary hypertension, or BPH Note: Subjects taking sildenafil or tadalafil for erectile disfunction will still be eligible.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCTA Group<br> | Device: Coronary CT Angiography (CCTA)<br>* Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.<br>|
| No Intervention: Usual Care Group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 6 months, and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Coronary Atherosclerosis, Quantitative Coronary CT Angiography, Androgen Deprivation Therapy