RightFit
RecruitingNot applicable

ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study compares a heart CT scan called CCTA with usual care to check for plaque buildup in heart arteries. It is for people with prostate cancer who are taking or plan to start androgen deprivation therapy (ADT), a treatment that lowers male hormones.

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) .

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form and give permission to share personal health information.
  • Be age 40 or older when you sign up.
  • Have prostate cancer and either be taking ADT now or plan to start ADT for more than 12 months.
  • You may also take abiraterone, enzalutamide, apalutamide, or darolutamide with ADT.
  • Have at least one heart disease risk factor: high blood pressure, high cholesterol, diabetes, or tobacco use.
  • Have no current heart symptoms.

Who can't join

  • Be receiving chemotherapy with docetaxel, cabazitaxel, or mitoxantrone when you sign the consent form.
  • Have a pacemaker or an implanted device that shocks the heart to correct its rhythm (ICD).
  • Have a history of heart artery stents, blocked heart arteries, a heart attack, or heart bypass surgery.
  • Have a history of atrial fibrillation, a type of uneven heartbeat.
  • Have poor kidney function, with a creatinine clearance below 35 mL/min.
  • Be allergic to iodine-based contrast dye used for scans.
  • Be unable to safely take medicines that may control heart rate during CCTA. This applies only if you are assigned to the scan group.
  • Take sildenafil or tadalafil to widen blood vessels, treat high blood pressure in the lungs, or treat an enlarged prostate. Taking them for erection problems is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (3)

IN