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Trial Title:
ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
NCT ID:
NCT05879913
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Coronary Atherosclerosis
Quantitative Coronary CT Angiography
Androgen Deprivation Therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Coronary CT Angiography (CCTA)
Description:
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive
technique for detection of coronary artery plaque.
Arm group label:
CCTA Group
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.
Criteria for 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.
Gender:
Male
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nishant M. Chenchaiah
Phone:
317-278-0070
Email:
nischenc@iu.edu
Investigator:
Last name:
Nabil Adra, MD
Email:
Principal Investigator
Start date:
December 15, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Indiana University
Agency class:
Other
Collaborator:
Agency:
National Comprehensive Cancer Network
Agency class:
Other
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
Myovant Sciences GmbH
Agency class:
Industry
Source:
Indiana University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05879913
