ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

Description

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) .

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

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) .

Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment With Quantitative Coronary CT Angiography (CCTA)

ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Suparna C. Clasen, MD, MSCE, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

2026-12