Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

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

NCT ID: NCT05879913Sponsor: Indiana UniversityLast updated: 2026-02-25

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) .

Detailed description

This is a randomized pilot study where subjects are randomized 1:1 to either the CCTA group or non-CCTA (usual care) group. The target enrollment will be 100 subjects with accounting for a potential 10% dropout rate resulting in an sample size between 90-100 participants or 45-50per group arm.

Arms & interventions

  • DeviceCoronary CT Angiography (CCTA)

    Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.

Outcome measures

Primary

  • Proportion of Atherosclerosis in CCTA Arm

    Proportion of prostate cancer patients without cardiac symptoms in the CCTA arm who are reclassified into a higher risk group using automated plaque assessment from CCTA that would otherwise be classed as low risk for ASCVD using the PCE

    Time frame: Baseline

  • Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA

    Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin

    Time frame: Baseline

Secondary

  • Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score

    Time frame: Baseline, 6 months, and 12 months

Eligibility criteria

Sex: MaleAge: 40 Years and olderHealthy volunteers: No
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.

Study locations (3)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032

Recruiting
Elizabeth Rowe · Contact
Abhishek Khemka, MD · Principal Investigator

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

Recruiting
Elizabeth Rowe · Contact
Abhishek Khemka, MD · Principal Investigator

Methodist Hospital

Indianapolis, Indiana, 46202

Recruiting
Elizabeth Rowe · Contact
Abhishek Khemka, MD · Principal Investigator
ASCVD Management Using CCTA in Prostate Cancer Patients on ADT | Cancerify