RecruitingNot ApplicableNCT05879913
ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment With Quantitative Coronary CT Angiography (CCTA)
Sponsor
Indiana University
Enrollment
100 participants
Start Date
Dec 15, 2023
Study Type
INTERVENTIONAL
Conditions
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) .
Eligibility
Sex: MALEMin Age: 40 Years
Inclusion Criteria6
- 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 Criteria8
- 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)
- Allergy to iodinated contrast
- 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)
- Patients taking sildenafil or tadalafil for vasodilation, pulmonary hypertension, or BPH
- Note: Subjects taking sildenafil or tadalafil for erectile disfunction will still be eligible.
Interventions
DEVICECoronary CT Angiography (CCTA)
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05879913
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