Coronary CT Angiography Scan in Prostate Cancer

Sponsor

Indiana University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05879913

Collaborator

National Comprehensive Cancer Network (Other), Pfizer (Industry), Myovant Sciences GmbH (Industry)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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) .

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: Coronary CT Angiography (CCTA)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Usual Care Group

Arm

Intervention/Treatment

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.

No Intervention: Usual Care Group

Outcome Measures

Primary Outcome Measures

Proportion of Atherosclerosis in CCTA Arm [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
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA [Baseline]
Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin

Secondary Outcome Measures

Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University
National Comprehensive Cancer Network
Pfizer
Myovant Sciences GmbH

Investigators

Principal Investigator: Suparna C. Clasen, MD, MSCE, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suparna C. Clasen, Medical Director of Cardio-Oncology, Assistant Professor in the Department of Medicine at Indiana University, Indiana University

ClinicalTrials.gov Identifier:

NCT05879913

Other Study ID Numbers:

CTO-IUSCCC-0807

First Posted:

May 30, 2023

Last Update Posted:

May 30, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Suparna C. Clasen, Medical Director of Cardio-Oncology, Assistant Professor in the Department of Medicine at Indiana University, Indiana University

Prostate Cancer

Coronary Atherosclerosis

Quantitative Coronary CT Angiography

Androgen Deprivation Therapy

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of May 30, 2023