Health TrialsbyHealthPanel

ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorIndiana University

About this trial

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) .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coronary CT Angiography (CCTA)

    Device

    Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: CCTA GroupExperimental treatment 1 intervention
Group B: Usual Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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 and PREVENT.

Time frame
Baseline
2

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

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline, 6 months, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

National Comprehensive Cancer Network

Collaborator

Pfizer

Collaborator

Sumitomo Pharma America, Inc.

Collaborator

Source ClinicalTrials.gov
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