NCT05879913

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) .

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
19mo left

Started Dec 2023

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Dec 2023Dec 2027

First Submitted

Initial submission to the registry

May 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

May 19, 2023

Last Update Submit

February 23, 2026

Conditions

Prostate Cancer

Keywords

Prostate CancerCoronary AtherosclerosisQuantitative Coronary CT AngiographyAndrogen Deprivation Therapy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score

    Baseline, 6 months, and 12 months

Study Arms (2)

CCTA Group

EXPERIMENTAL
Device: Coronary CT Angiography (CCTA)

Usual Care Group

NO INTERVENTION

Interventions

Coronary CT Angiography (CCTA)DEVICE

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

CCTA Group

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsCoronary Artery Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Abhishek Khemka, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Rowe

CONTACT

(317) 278-1185rowee@iu.edu

Abhishek Khemka, MD

CONTACT

(317) 962-0500akhemka@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Medicine in Division of Cardiovascular Medicine

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 30, 2023

Study Start

December 15, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

US(3)