Clinical trial NCT05879913: ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
Official title: Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment with Quantitative Coronary CT Angiography (CCTA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Coronary Atherosclerosis
Quantitative Coronary CT Angiography
Androgen Deprivation Therapy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
name: Pfizer
name: Sumitomo Pharmaceuticals America
First posted: 2023-05-30
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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) .

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.

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.

Primary outcomes:
measure: Proportion of Atherosclerosis in CCTA Arm
timeFrame: Baseline
measure: Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
timeFrame: Baseline
Secondary outcomes:
measure: Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
timeFrame: Baseline, 6 months, and 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Suparna C. Clasen, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: