Prostate Cancer
Conditions
Keywords
Prostate Cancer, Coronary Atherosclerosis, Quantitative Coronary CT Angiography, Androgen Deprivation Therapy
Brief 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.
Interventions
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
Sponsors
Indiana University
National Comprehensive Cancer Network
Pfizer
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Atherosclerosis in CCTA Arm | Baseline | 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 |
| Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA | Baseline | Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score | Baseline, 6 months, and 12 months | Changes in risk over time with intensive medical treatment tailored to plaque burden to test results in a reduction in cardiovascular risk factors including blood pressure, glucose and lipid levels, thus reducing the ASCVD risk score. |
Countries
United States
Contacts
CONTACTElizabeth Rowe
CONTACTAbhishek Khemka, MD
PRINCIPAL_INVESTIGATORAbhishek Khemka, MD
Indiana University
Outcome results
None listed