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ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

RECRUITINGN/ASponsored by Indiana University
Actively Recruiting
PhaseN/A
SponsorIndiana University
Started2023-12-15
Est. completion2026-12
Eligibility
Age40 Years+
SexMALE
Healthy vol.Accepted
Locations3 sites

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

Age: 40 Years+Sex: MALEHealthy volunteers accepted
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.

Conditions3

CancerHeart DiseaseProstate Cancer

Locations3 sites

IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
Elizabeth Rowe317-278-1185rowee@iu.edu
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Elizabeth Rowe317-278-1185rowee@iu.edu
Methodist Hospital
Indianapolis, Indiana, 46202
Elizabeth Rowe317-278-1185rowee@iu.edu

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