Using Coronary CT Angiography to Manage Heart Health in Prostate Cancer Patients on Hormone Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the effectiveness of Coronary CT Angiography (CCTA) in assessing coronary atherosclerosis in prostate cancer patients who are either starting or currently undergoing androgen deprivation therapy (ADT). Participants will be randomly assigned to either the CCTA group or a usual care group, with a target enrollment of 100 subjects. The study aims to evaluate whether CCTA can provide better management of cardiovascular risks compared to standard care in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• IU Health Joe and Shelly Schwarz Cancer Center
  Carmel, Indiana, United States Recruiting
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center
  Indianapolis, Indiana, United States Recruiting
• Methodist Hospital
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Abhishek Khemka, MD — Indiana University
• Study coordinator: Elizabeth Rowe
• Email: rowee@iu.edu
• Phone: (317) 278-1185

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.