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

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

This study is testing if using a special heart scan can help doctors better manage heart health in prostate cancer patients who are on hormone therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 40 Years and up
• Sex: Male
• Sponsor: Indiana University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Carmel, Indiana and 2 other locations)
• Trial ID: NCT05879913 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men aged 40 and older with a diagnosis of prostate cancer who are currently receiving or planning to start ADT and have at least one risk factor for atherosclerotic cardiovascular disease.

Not a fit: Patients with a history of significant cardiac issues or those currently undergoing chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance cardiovascular risk management in prostate cancer patients undergoing ADT.

How similar studies have performed: While there have been studies on cardiovascular risks in cancer patients, the specific use of CCTA in this context is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Carmel, Indiana and 2 other locations

• 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

Conditions Prostate Cancer; Coronary Atherosclerosis; Quantitative Coronary CT Angiography; Androgen Deprivation Therapy