Prostate CancerNCT05879913
ASCVD Management Using CCTA in Prostate Cancer Patients on ADT
A study testing Coronary CT Angiography (CCTA) in people with Prostate Cancer, run by Indiana University at 3 sites in United States.
Trial 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) . Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Coronary CT Angiography (CCTA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Dec 2023to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
Elizabeth Rowe, 317-278-1185, rowee@iu.edu
Abhishek Khemka, MD
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Elizabeth Rowe, 317-278-1185, rowee@iu.edu
Abhishek Khemka, MD
- Recruiting
Methodist Hospital
Indianapolis, Indiana, 46202
Elizabeth Rowe, 317-278-1185, rowee@iu.edu
Abhishek Khemka, MD
About this study
Official title: Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment With Quantitative Coronary CT Angiography (CCTA)
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) .
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Coronary CT Angiography (CCTA)
- Keywords
- Prostate Cancer, Coronary Atherosclerosis, Quantitative Coronary CT Angiography, Androgen Deprivation Therapy
- Medical subject headings
- Prostatic Neoplasms, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT Angiography (CCTA)Device
Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.
| Study group | Role | What they receive |
|---|---|---|
| CCTA Group | Experimental | Not described Receives: Device: Coronary CT Angiography (CCTA) |
| Usual Care Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 and PREVENT.
Measured: Baseline
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
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start15 Dec 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Pfizer, Sumitomo Pharma America, Inc.
- Responsible party
- Principal investigator, Abhishek Khemka, Indiana University
- Investigators
- Abhishek Khemka, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879913
- Sponsor's protocol ID
- CTO-IUSCCC-0807
- Status last verified
- Sep 2026
- First submitted
- 19 May 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment With Quantitative Coronary CT Angiography (CCTA)
- ClinicalTrials.gov ID
- NCT05879913
- Acronym / sponsor ID
- CTO-IUSCCC-0807
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Coronary Atherosclerosis, Quantitative Coronary CT Angiography, Androgen Deprivation Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Pfizer, Sumitomo Pharma America, Inc.
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCTA Group | Experimental | Device: Coronary CT Angiography (CCTA) |
| Usual Care Group | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary CT Angiography (CCTA)Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque. | Device | CCTA Group |
Primary outcome
Proportion of Atherosclerosis in CCTA Arm
Time frame: Baseline
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 and PREVENT.
Proportion of Subjects Eligible for Treatment Based on Automated Plaque Assessment from CCTA
Time frame: Baseline
Assessment of automated plaque from CCTA determining eligibility of lipid lowering treatment and aspirin
1 secondary outcome
Reduction in atherosclerotic cardiovascular disease (ASCVD) risk score
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abhishek Khemka, MD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary CT Angiography (CCTA) in people with Prostate Cancer, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Rowe ((317) 278-1185, rowee@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Atherosclerosis in CCTA Arm (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.