ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
Recruiting · NCT05879913 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Coronary CT Angiography (CCTA)
What this trial is about
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) .
Who can take part
Age range
40 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
3 locations listed across 1 US state.
- IU Health Joe and Shelly Schwarz Cancer Center - Carmel, Indiana, United States
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis, Indiana, United States
- Methodist Hospital - Indianapolis, Indiana, United States