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NCT05879913NARecruiting

ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

Indiana University

Start Date

12/15/2023

Completion Date

12/1/2027

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.

Eligibility Criteria

Age Range: 40 years to No maximum

Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information 2. Age ≥40 years at time of consent 3. Previous diagnosis of prostate cancer who are either currently receiving ADT, or who are planning to start ADT for \>12 months 4. Patients currently on or planned for treatment with ADT plus androgen pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) are allowed 5. ≥1 risk factor for ASCVD (hypertension, hyperlipidemia, diabetes, tobacco use) 6. No current cardiac symptoms Exclusion Criteria: 1. Concurrent treatment with chemotherapy (docetaxel, cabazitaxel, mitoxantrone) at time of signing consent 2. Patient has implantable cardioverter-defibrillator (ICD), or pacemaker 3. History of coronary stents, obstructive coronary artery disease, myocardial infarction, coronary artery bypass grafting. History of atrial fibrillation 4. Renal dysfunction with creatinine clearance \<35ml/min (calculated by Cockcroft-Gault Equation) 5. Allergy to iodinated contrast 6. 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) 7. Patients taking sildenafil or tadalafil for vasodilation, pulmonary hypertension, or BPH 1. Note: Subjects taking sildenafil or tadalafil for erectile disfunction will still be eligible.

Interventions

DEVICE

Coronary CT Angiography (CCTA)

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Conditions

Prostate Cancer

Locations

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana 46032

United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana 46202

United States

Methodist Hospital

Indianapolis, Indiana 46202

United States