This clinical trial evaluates plaque assessment with cardiac computed tomography angiography (CCTA) in the management of atherosclerotic cardiovascular disease (ASCVD) in prostate cancer patients on androgen deprivation therapy (ADT). ADT, a standard treatment for men with prostate cancer, may be associated with an increased risk of heart disease including thickening or hardening of the arteries caused by a buildup of plaque in the inner lining of an artery (ASCVD). A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. CCTA is a type of CT imaging test that looks at the arteries that supply blood to the heart and is an accurate non-invasive technique to detect artery plaque, but is not usually used in patients without symptoms. Plaque assessment using CCTA may identify early atherosclerosis and guide treatment in patients with prostate cancer on ADT.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05879913.
Locations matching your search criteria
United States
Indiana
Indianapolis
Indiana University/Melvin and Bren Simon Cancer CenterStatus: Active
Contact: Abhishek Khemka
Phone: 317-962-0500
PRIMARY OBJECTIVES:
Ia. To use quantitative CCTA to define the prevalence of ASCVD in men with prostate cancer receiving ADT.
Ib. To use quantitative CCTA to characterize gaps in treatment of ASCVD and its risk factors by identifying patients with atherosclerosis who are not receiving optimal medical treatment.
SECONDARY OBJECTIVE:
I. Demonstrate that CCTA-based plaque assessment followed by evidence-based treatments for cardiovascular risk factors such as hypertension, hyperlipidemia, and hyperglycemia will be associated with reduction in clinical and serologic markers that predict long-term risk of adverse cardiovascular events.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients attend outpatient clinic visits, receive cardiovascular standard of care treatment and undergo CCTA on study. Patients also undergo blood sample collection throughout the trial.
GROUP II: Patients attend outpatient clinic visits and receive cardiovascular standard of care treatment on study. Patients also undergo blood sample collection throughout the trial.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorAbhishek Khemka
