NCT05879913 ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
| NCT ID | NCT05879913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-12-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) .
Eligibility Criteria
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.
Contact & Investigator
Abhishek Khemka, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05879913 clinical trial?
This trial is open to male participants only, aged 40 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05879913 currently recruiting?
Yes, NCT05879913 is actively recruiting participants. Contact the research team at rowee@iu.edu for enrollment information.
Where is the NCT05879913 trial being conducted?
This trial is being conducted at Carmel, United States, Indianapolis, United States, Indianapolis, United States.
Who is sponsoring the NCT05879913 clinical trial?
NCT05879913 is sponsored by Indiana University. The principal investigator is Abhishek Khemka, MD at Indiana University. The trial plans to enroll 100 participants.
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