ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
NCT ID: NCT05879913
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-12-15
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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CCTA Group
Coronary CT Angiography (CCTA)
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
Usual Care Group
No interventions assigned to this group
Interventions
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Coronary CT Angiography (CCTA)
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
MALE
No
Sponsors
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National Comprehensive Cancer Network
NETWORK
Pfizer
INDUSTRY
Sumitomo Pharmaceuticals America
INDUSTRY
Indiana University
OTHER
Responsible Party
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Abhishek Khemka
Associate Professor of Clinical Medicine in Division of Cardiovascular Medicine
Principal Investigators
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Abhishek Khemka, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTO-IUSCCC-0807
Identifier Type: -
Identifier Source: org_study_id
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