Back to resultsASCVD Management Using CCTA in Prostate Cancer Patients on ADT
Primary Purpose
Prostate Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coronary CT Angiography (CCTA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Coronary Atherosclerosis, Quantitative Coronary CT Angiography, Androgen Deprivation Therapy
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CCTA Group
Usual Care Group
Arm Description
Outcomes
Primary Outcome Measures
Proportion of Atherosclerosis in CCTA Arm
Proportion of prostate cancer patients without cardiac symptoms in the CCTA arm who are reclassified into a higher risk group using automated plaque assessment from CCTA that would otherwise be classed as low risk for ASCVD using the PCE
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin
Secondary Outcome Measures
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
Changes in risk over time with intensive medical treatment tailored to plaque burden to test results in a reduction in cardiovascular risk factors including blood pressure, glucose and lipid levels, thus reducing the ASCVD risk score.
Full Information
NCT ID
NCT05879913
First Posted
May 19, 2023
Last Updated
September 29, 2023
Sponsor
Indiana University
Collaborators
National Comprehensive Cancer Network, Pfizer, Myovant Sciences GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05879913
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Comprehensive Cancer Network, Pfizer, Myovant Sciences GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Coronary Atherosclerosis, Quantitative Coronary CT Angiography, Androgen Deprivation Therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CCTA Group
Arm Type
Experimental
Arm Title
Usual Care Group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Coronary CT Angiography (CCTA)
Intervention Description
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
Primary Outcome Measure Information:
Title
Proportion of Atherosclerosis in CCTA Arm
Description
Proportion of prostate cancer patients without cardiac symptoms in the CCTA arm who are reclassified into a higher risk group using automated plaque assessment from CCTA that would otherwise be classed as low risk for ASCVD using the PCE
Time Frame
Baseline
Title
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
Description
Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
Description
Changes in risk over time with intensive medical treatment tailored to plaque burden to test results in a reduction in cardiovascular risk factors including blood pressure, glucose and lipid levels, thus reducing the ASCVD risk score.
Time Frame
Baseline, 6 months, and 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nishant M. Chenchaiah
Phone
317-278-0070
Email
nischenc@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Suparna C. Clasen, MD, MSCE
Phone
(317) 963-5462
Email
scclasen@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suparna C. Clasen, MD, MSCE
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nishant M. Chenchaiah
Phone
317-278-0070
Email
nischenc@iu.edu
First Name & Middle Initial & Last Name & Degree
Nabil Adra, MD
12. IPD Sharing Statement
Learn more about this trial
ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
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