ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

Launched by INDIANA UNIVERSITY · May 19, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a special heart scan called Coronary CT Angiography (CCTA) can help manage heart health in men with prostate cancer who are undergoing a treatment called androgen deprivation therapy (ADT). The study is comparing this advanced heart scan to standard care to see which approach is better for spotting heart problems, specifically a condition called coronary atherosclerosis, which is the buildup of fats and cholesterol in the arteries that can lead to heart disease.

To participate in the trial, men must be at least 40 years old and have a diagnosis of prostate cancer. They should either be receiving ADT or plan to start it for more than a year, and have at least one risk factor for heart disease, like high blood pressure or diabetes. Participants will not have any current heart symptoms. If eligible, they can expect to undergo the heart scan and receive regular check-ups as part of their care. It's important to note that this study is currently recruiting participants, so those who meet the criteria can help contribute to valuable research in this area.

Gender

MALE

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.