ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
Conditions
Prostate CancerSummary
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
- Nishant M. Chenchaiah
- 317-278-0070
- [email protected]
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
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
Secondary Outcome Measures
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
Timeline
Last Updated
May 1, 2024Start Date
May 30, 2023Today
January 16, 2025Completion Date ( Estimated )
December 1, 2026
Sponsors of this trial
Lead Sponsor
Indiana UniversityCollaborating Sponsors
National Comprehensive Cancer Network, Pfizer, Myovant Sciences GmbH