ASCVD Management Using CCTA in Prostate Cancer Patients on 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.

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.