ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

NCT ID: NCT05879913

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2027-12-31

Brief Summary

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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) .

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CCTA Group

Group Type EXPERIMENTAL

Coronary CT Angiography (CCTA)

Intervention Type DEVICE

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

Usual Care Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Coronary CT Angiography (CCTA)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Comprehensive Cancer Network

NETWORK

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Sumitomo Pharmaceuticals America

INDUSTRY

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Abhishek Khemka

Associate Professor of Clinical Medicine in Division of Cardiovascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abhishek Khemka, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, United States

Site Status RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Site Status RECRUITING

Methodist Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elizabeth Rowe

Role: CONTACT

(317) 278-1185

Abhishek Khemka, MD

Role: CONTACT

(317) 962-0500

Facility Contacts

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Elizabeth Rowe

Role: primary

(317) 278-1185

Elizabeth Rowe

Role: primary

(317) 278-1185

Elizabeth Rowe

Role: primary

(317) 278-1185

Other Identifiers

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CTO-IUSCCC-0807

Identifier Type: -

Identifier Source: org_study_id

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