RECRUITING

ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

Conditions

Prostate Cancer Coronary Atherosclerosis Quantitative Coronary CT Angiography Androgen Deprivation Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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) .

Official Title

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

Quick Facts

Study Start:2023-12-15

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05879913

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.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Nishant M. Chenchaiah

CONTACT

317-278-0070

nischenc@iu.edu

Suparna C. Clasen, MD, MSCE

CONTACT

(317) 963-5462

scclasen@iu.edu

Principal Investigator

Suparna C. Clasen, MD, MSCE

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

Suparna C. Clasen, MD, MSCE, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-12-15

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-12-15

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Prostate Cancer
Coronary Atherosclerosis
Quantitative Coronary CT Angiography
Androgen Deprivation Therapy

Additional Relevant MeSH Terms

Prostate Cancer