ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary CT Angiography (CCTA).
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 40 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment With Quantitative Coronary CT Angiography (CCTA)
Overview
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) .
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.
Interventions
- Device Coronary CT Angiography (CCTA)
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score [Time frame: Baseline, 6 months, and 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 3 centers
- IU Health Joe and Shelly Schwarz Cancer Center — Carmel
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
- Methodist Hospital — Indianapolis
Identifiers
NCT: NCT05879913 · CTO-IUSCCC-0807