Prostatic NeoplasmsNCT04652973
Evaluation of Atherosclerotic Plaques in Abdominal CT Studies
An observational study of Prostatic Neoplasms, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Fat and calcium can build up as plaque in artery walls. The Agatston score measures plaque using computed tomography (CT) that does not use an injected contrast agent. Plaque in the arteries of the pelvis and abdomen is linked to cardiovascular disease (CVD) risk factors. It also may affect cancer. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 30 Aug 2030
- Phase
- Observational
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two separate study populations were recruited. The "Prostate cancer dataset" consisted of biopsy-proven prostate cancer patients who have abdomen CT studies that were available in the clinical PACS (picture archiving system) in the Clinical Center. Men of all ages and races are included. The "Multiphase CT dataset" consisted of men or women of all age and race, who have Multiphase abdomen-pelvic CT studies that were available in the PACS.
Who may be able to join
- The study will use existing radiologic data.
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Fat and calcium can build up as plaque in artery walls. The Agatston score measures plaque using computed tomography (CT) that does not use an injected contrast agent. Plaque in the arteries of the pelvis and abdomen is linked to cardiovascular disease (CVD) risk factors. It also may affect cancer. But abdominal CTs use a contrast agent (CECT). Therefore, the Agatston score cannot be used. Researchers want to find a way to measure plaque in CECTs. This will help them use abdominal CTs to measure plaque without extra radiation.
Read more
Objective:
To measure atherosclerotic plaques on CECT in a group of males.
Eligibility:
Men ages 30-90 with prostate cancer (proven with biopsies) who have abdomen CT studies in the PACS (picture archiving system) in the Clinical Center. Also, men or women of all ages who have multiphase abdomen and pelvic CT studies that are in the PACS.
Design:
This study will use data gathered since 1/1/2013. Data will also be taken from protocol 03-CC-0128 and clinical trials 15-C-0124, 16-C-0048, 14-C-0112, and 04-C-0274. Participants from these studies have allowed their samples to be used in the future.
Participants will be found via keyword searches on NIH databases. Their CT and MRI scans will be used. Data such as age, race, disease, and treatment will be used. Results of other tests may be used.
The plaque in participants abdomen and iliac arteries will be measured. It will be compared with biomarkers related to CVD and prostate cancer, such as weight, age, and race.
This study will take place at one site. Data will be stored on secure computers. Printouts will be kept in locked rooms.
Read the detailed description
Evaluation of Atherosclerotic Plaques in Prostate Cancer Patients.
Study Description:
This study measures atherosclerotic plaques in the vessels of prostate cancer patients in contrast-enhanced computed tomography (CECT), then finds correlation between the plaque and clinical biomarkers. These biomarkers include laboratory tests, pathologic findings, underlying risk factors, demographic information, and outcomes of the patient.
Objectives:
Primary objective: Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT).
Secondary objective: Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients.
Study Population:
Up to 1,000 NIH Clinical Center patients.
Description of Sites/Facilities conducting research:
NIH Clinical Center
Study Duration:
10 years
- Conditions
- Prostatic Neoplasms
- Keywords
- CT measurement, CVD, CT coronary angiogram, clinical biomarkers, Natural History
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Prostate cancer dataset | Biopsy-proven prostate cancer patients who have abdomen CT studies that were available in the clinical PACS (picture archiving system) in the Clinical Center. | |
| 2/Multiphase CT dataset | Men or women of all age and race, who have Multiphase abdomen-pelvic CT studies that were available in the PACS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1/Measure atherosclerotic plaques
Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT)
Measured: End of study
Secondary outcomes (1)
2/Plaque measurement and clinical biomarkers correlation
Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start19 Nov 2020
- Primary completion30 Aug 2030 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ronald M Summers, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652973
- Sponsor's protocol ID
- 10000123
- Other IDs
- 000123-CC
- Status last verified
- 28 Sep 2026
- First submitted
- 3 Dec 2020
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Atherosclerotic Plaques in Abdominal CT Studies
- ClinicalTrials.gov ID
- NCT04652973
- Acronym / sponsor ID
- 10000123
- Conditions
- Prostatic Neoplasms
- Keywords
- CT measurement, CVD, CT coronary angiogram, clinical biomarkers, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 30 Aug 2030 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 4 Dec 2020 (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.
Background:
Fat and calcium can build up as plaque in artery walls. The Agatston score measures plaque using computed tomography (CT) that does not use an injected contrast agent. Plaque in the arteries of the pelvis and abdomen is linked to cardiovascular disease (CVD) risk factors. It also may affect cancer. But abdominal CTs use a contrast agent (CECT). Therefore, the Agatston score cannot be used. Researchers want to find a way to measure plaque in CECTs. This will help them use abdominal CTs to measure plaque without extra radiation.
Objective:
To measure atherosclerotic plaques on CECT in a group of males.
Eligibility:
Men ages 30-90 with prostate cancer (proven with biopsies) who have abdomen CT studies in the PACS (picture archiving system) in the Clinical Center. Also, men or women of all ages who have multiphase abdomen and pelvic CT studies that are in the PACS.
Design:
This study will use data gathered since 1/1/2013. Data will also be taken from protocol 03-CC-0128 and clinical trials 15-C-0124, 16-C-0048, 14-C-0112, and 04-C-0274. Participants from these studies have allowed their samples to be used in the future.
Participants will be found via keyword searches on NIH databases. Their CT and MRI scans will be used. Data such as age, race, disease, and treatment will be used. Results of other tests may be used.
The plaque in participants abdomen and iliac arteries will be measured. It will be compared with biomarkers related to CVD and prostate cancer, such as weight, age, and race.
This study will take place at one site. Data will be stored on secure computers. Printouts will be kept in locked rooms.
Detailed description
Evaluation of Atherosclerotic Plaques in Prostate Cancer Patients.
Study Description:
This study measures atherosclerotic plaques in the vessels of prostate cancer patients in contrast-enhanced computed tomography (CECT), then finds correlation between the plaque and clinical biomarkers. These biomarkers include laboratory tests, pathologic findings, underlying risk factors, demographic information, and outcomes of the patient.
Objectives:
Primary objective: Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT).
Secondary objective: Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients.
Study Population:
Up to 1,000 NIH Clinical Center patients.
Description of Sites/Facilities conducting research:
NIH Clinical Center
Study Duration:
10 years
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Prostate cancer dataset | – | –Biopsy-proven prostate cancer patients who have abdomen CT studies that were available in the clinical PACS (picture archiving system) in the Clinical Center. |
| 2/Multiphase CT dataset | – | –Men or women of all age and race, who have Multiphase abdomen-pelvic CT studies that were available in the PACS. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two separate study populations were recruited. The "Prostate cancer dataset" consisted of biopsy-proven prostate cancer patients who have abdomen CT studies that were available in the clinical PACS (picture archiving system) in the Clinical Center. Men of all ages and races are included. The "Multiphase CT dataset" consisted of men or women of all age and race, who have Multiphase abdomen-pelvic CT studies that were available in the PACS.
Key inclusion criteria (1 listed)
- The study will use existing radiologic data.
Key exclusion criteria (1 listed)
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1/Measure atherosclerotic plaques
Time frame: End of study
Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT)
1 secondary outcome
2/Plaque measurement and clinical biomarkers correlation
Time frame: End of study
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 30 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Ronald M Summers, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by National Institutes of Health Clinical Center (CC) at 1 site 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1/Measure atherosclerotic plaques (time frame: End of study). 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 30 Sep 2026.