ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

Clinicaltrials.gov ID: NCT05879913
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 40 Years
b-bullseye-arrow Enrollments 100

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Suparna C. Clasen, MD, MSCE

Eligibility Criteria

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 Plan

CCTA Group

  • DEVICE:

    Coronary CT Angiography (CCTA)

    Description:

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

Usual Care Group

    Outcome Measures

    Primary Outcome Measures

    Proportion of Atherosclerosis in CCTA Arm

    Time Frame: Baseline

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

    Time Frame: Baseline

    Secondary Outcome Measures

    Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score

    Time Frame: Baseline, 6 months, and 12 months

    Timeline

    • Last Updated
      May 1, 2024
    • Start Date
      May 30, 2023
    • Today
      January 16, 2025
    • Completion Date ( Estimated )
      December 1, 2026

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