ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
Investigating Heart Health in Prostate Cancer Patients on Hormone Therapy
Suparna C. Clasen, MD, MSCE
Primary Investigator
Brief description of study
Detailed description of study
- 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Prostate Cancer
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Age: 40 years or above
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Gender: Male
- 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
- 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.
This study investigates how Coronary CT Angiography (CCTA) can be used to look at heart health in people with prostate cancer who are on hormone therapy called androgen deprivation therapy (ADT). Prostate cancer is a condition where cells in the prostate grow uncontrollably. ADT is a treatment that lowers male hormones to slow the growth of cancer. This study will compare two study arms: one group will receive the CCTA scan to check their heart health, and the other group will continue with their usual care without the scan.
Participants will be randomly assigned to one of the two study arms. Those in the CCTA arm will undergo a special scan that looks at the heart's blood vessels to check for any issues. The study aims to enroll around 100 participants, split evenly between the two study arms. The procedures involved in the study will help doctors learn more about the heart health of prostate cancer patients on ADT.
- Who can participate: Men aged 40 years or older with a diagnosis of prostate cancer who are either receiving or planning to start hormone therapy for over 12 months can participate. Participants should have at least one heart disease risk factor, such as high blood pressure or diabetes, and no current heart symptoms.
- Study details: Participants will either have a heart scan called CCTA (Coronary CT Angiography), which helps doctors see the heart's blood vessels without needing surgery, or continue with their usual care.
