ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

September 30, 2026 updated by: Abhishek Khemka, Indiana University

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

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) .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elizabeth Rowe
  • Phone Number: (317) 278-1185
  • Email: rowee@iu.edu

Study Contact Backup

  • Name: Abhishek Khemka, MD
  • Phone Number: (317) 962-0500
  • Email: akhemka@iu.edu

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • IU Health Joe and Shelly Schwarz Cancer Center
        • Contact:
          • Elizabeth Rowe
          • Phone Number: 317-278-1185
          • Email: rowee@iu.edu
        • Principal Investigator:
          • Abhishek Khemka, MD
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
        • Contact:
          • Elizabeth Rowe
          • Phone Number: 317-278-1185
          • Email: rowee@iu.edu
        • Principal Investigator:
          • Abhishek Khemka, MD
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Methodist Hospital
        • Contact:
          • Elizabeth Rowe
          • Phone Number: 317-278-1185
          • Email: rowee@iu.edu
        • Principal Investigator:
          • Abhishek Khemka, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care Group
Experimental: CCTA Group
Device: Coronary CT Angiography (CCTA)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Atherosclerosis in CCTA Arm
Time Frame: 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 and PREVENT.
Baseline
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
Time Frame: Baseline

Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
Time Frame: 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.
Baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Pfizer
National Comprehensive Cancer Network
Sumitomo Pharma America, Inc.

Investigators

  • Principal Investigator: Abhishek Khemka, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2026

Last Update Submitted That Met QC Criteria

September 30, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO-IUSCCC-0807

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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