ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Coronary CT Angiography (CCTA)

• Registration Number: NCT05879913
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-30
• Study Start: 2023-12-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCTA Group	Coronary CT Angiography (CCTA)	-

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA	Baseline	Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin
Proportion of Atherosclerosis in CCTA Arm	Baseline	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

Secondary Outcome Measures

Name	Time	Method
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score	Baseline, 6 months, and 12 months	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.

Trial Locations

Locations (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States