Prostate Cancer Clinical Trial

ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

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) .

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Written informed consent and HIPAA authorization for release of personal health information
Age ≥40 years at time of consent
Previous diagnosis of prostate cancer who are either currently receiving ADT, or who are planning to start ADT for >12 months
Patients currently on or planned for treatment with ADT plus androgen pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) are allowed
≥1 risk factor for ASCVD (hypertension, hyperlipidemia, diabetes, tobacco use)
No current cardiac symptoms

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

Note: Subjects taking sildenafil or tadalafil for erectile disfunction will still be eligible.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

100

Study ID:

NCT05879913

Recruitment Status:

Recruiting

Sponsor:

Indiana University

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There is 1 Location for this study

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Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis Indiana, 46202, United States More Info
Nishant M. Chenchaiah
Contact
317-278-0070
[email protected]
Nabil Adra, MD
Principal Investigator

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

100

Study ID:

NCT05879913

Recruitment Status:

Recruiting

Sponsor:


Indiana University

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