No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Male
Study type
Interventional
Purpose
Diagnostic
Participants needed
100 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
This trial is looking for men age 40 or older with prostate cancer who are currently receiving or planning to start hormone therapy for more than a year. Participants will be randomly assigned to receive either a specific heart imaging test or usual care to monitor heart health.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with prostate cancer
I am age 40 or older
I am currently using hormone therapy or plan to start it for more than a year
I have at least one risk factor for heart disease
I do not have current heart symptoms
You may not be able to join if
I am receiving chemotherapy right now
I have a heart device like a pacemaker or defibrillator
I have a history of heart disease or heart surgery
I have severe kidney problems
I am allergic to iodinated contrast
I cannot take medications to control my heart rate for the test
I take sildenafil or tadalafil for certain health issues
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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) .
Trial Locations
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Status
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 curren…
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.
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