Recruiting

CCTA with ADT

Sponsor:

Indiana University

Code:

NCT05879913

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Coronary CT Angiography (CCTA)

Study Details

Brief 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) .

Conditions

Prostate Cancer

Study ID

NCT05879913

Start date

Dec 15, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CCTA Group

no intervention: Usual Care Group

Interventions

Coronary CT Angiography (CCTA)

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

Primary outcome measure

  • Proportion of Atherosclerosis in CCTA Arm [ Time Frame: Baseline ]
  • Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

IU Health Joe and Shelly Schwarz Cancer Center

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Principal Investigator:

Abhishek Khemka, MD

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Abhishek Khemka, MD

Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Abhishek Khemka, MD

More Information

Sponsor

Indiana University

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • Prostate Cancer
  • Coronary Atherosclerosis
  • Quantitative Coronary CT Angiography
  • Androgen Deprivation Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-02-25.