RecruitingNot Applicable

ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

United States100 participantsStarted 2023-12-15

Plain-language 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) .

Who can participate

Age range40 Years

SexMALE

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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.

What they're measuring

Proportion of Atherosclerosis in CCTA Arm

Timeframe: Baseline

Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA

Timeframe: Baseline

Trial details

NCT IDNCT05879913

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Elizabeth Rowe

(317) 278-1185 rowee@iu.edu

View on ClinicalTrials.gov More Prostate Cancer trials