ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879913
• Other study ID #: CTO-IUSCCC-0807
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: Nishant M. Chenchaiah
• Phone: 317-278-0070
• Email: nischenc[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University	Myovant Sciences GmbH, National Comprehensive Cancer Network, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Baseline
Primary	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
Secondary	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