Prostate CancerNCT04981223
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
A study testing ExactVu in people with Prostate Cancer, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools. Read more about this study
- Who is it for?
- Ages 18 to 89 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ExactVu
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 26 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
- Agree to consent to the study
Who cannot join
- Does not agree to consent.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.
- Conditions
- Prostate Cancer
- Being tested
- ExactVu
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExactVuDevice
clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
| Study group | Role | What they receive |
|---|---|---|
| ExactVu Imaging | Experimental | EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of:
1. The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex)
2. The peripheral zone using the highest zoom setting (30mm depth) on the system (may require 2 sweeps to cover base and apex). Analysis of these images will be performed after surgery but before prostatectomy Receives: Device: ExactVu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
Evaluate the ability of micro-ultrasound to identify high grade prostate cancer foci (Gleason score ≥7) in comparison to final surgical pathology result (prostatectomy or biopsy)
Measured: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)
Secondary outcomes (4)
Prostate Cancer Border Identification Post-Prostatectomy
Evaluate the ability of micro-ultrasound to identify the borders of prostate cancer foci in comparison to final surgical pathology result in men after prostatectomy.
Measured: 3 years
Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)
Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6)
Measured: 1 year and 10 months
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI).
Measured: 1 year and 10 months
Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation
Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Apr 2022
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey Sonn, Stanford University
- Investigators
- Geoffrey Sonn, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981223
- Sponsor's protocol ID
- IRB-58101
- Other IDs
- NCI-2022-05158
- Status last verified
- May 2026
- First submitted
- 9 Jul 2021
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zhou SR, Choi MH, Vesal S, Kinnaird A, Brisbane WG, Lughezzani G, Maffei D, Fasulo V, Albers P, Zhang L, Kornberg Z, Fan RE, Shao W, Rusu M, Sonn GA. Inter-reader Agreement for Prostate Cancer Detection Using Micro-ultrasound: A Multi-institutional Study. Eur Urol Open Sci. 2024 Jul 13;66:93-100. doi: 10.1016/j.euros.2024.06.017. eCollection 2024 Aug.
PubMed 39076245
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT04981223
- Acronym / sponsor ID
- IRB-58101
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExactVu Imaging | Experimental | Device: ExactVuEV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: 1. The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) 2. The peripheral zone using the highest zoom setting (30mm depth) on the system (may require 2 sweeps to cover base and apex). Analysis of these images will be performed after surgery but before prostatectomy |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
- Agree to consent to the study
Key exclusion criteria (1 listed)
- Does not agree to consent.
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 |
|---|---|---|
| ExactVuclinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging | Device | ExactVu Imaging |
Primary outcome
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
Time frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)
Evaluate the ability of micro-ultrasound to identify high grade prostate cancer foci (Gleason score ≥7) in comparison to final surgical pathology result (prostatectomy or biopsy)
4 secondary outcomes
Prostate Cancer Border Identification Post-Prostatectomy
Time frame: 3 years
Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)
Time frame: 1 year and 10 months
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
Time frame: 1 year and 10 months
Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39076245Zhou SR, Choi MH, Vesal S, Kinnaird A, Brisbane WG, Lughezzani G, Maffei D, Fasulo V, Albers P, Zhang L, Kornberg Z, Fan RE, Shao W, Rusu M, Sonn GA. Inter-reader Agreement for Prostate Cancer Detection Using Micro-ultrasound: A Multi-institutional Study. Eur Urol Open Sci. 2024 Jul 13;66:93-100. doi: 10.1016/j.euros.2024.06.017. eCollection 2024 Aug.
- Individual participant dataSharing planned: No
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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.
Geoffrey Sonn principal investigator
Stanford Universiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExactVu in people with Prostate Cancer, run by Stanford University 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 2 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: finished, as of the sponsor's last update on 28 May 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?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology (time frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981223, which also lists 1 linked publication.
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 28 May 2026.