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 range

40 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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