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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
| Pfizer | INDUSTRY |
| Sumitomo Pharma America, Inc. | INDUSTRY |
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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) .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCTA Group | Experimental |
| |
| Usual Care Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary CT Angiography (CCTA) | Device | Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score | 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. | Baseline, 6 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Concurrent treatment with chemotherapy (docetaxel, cabazitaxel, mitoxantrone) at time of signing consent
Patient has implantable cardioverter-defibrillator (ICD), or pacemaker
History of coronary stents, obstructive coronary artery disease, myocardial infarction, coronary artery bypass grafting. History of atrial fibrillation
Renal dysfunction with creatinine clearance <35ml/min (calculated by Cockcroft-Gault Equation)
Allergy to iodinated contrast
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)
Patients taking sildenafil or tadalafil for vasodilation, pulmonary hypertension, or BPH
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Rowe | Contact | (317) 278-1185 | rowee@iu.edu | |
| Abhishek Khemka, MD | Contact | (317) 962-0500 | akhemka@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Abhishek Khemka, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Joe and Shelly Schwarz Cancer Center | Recruiting | Carmel | Indiana | 46032 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| Methodist Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |