Prostate CancerOU-SCC-PROBXNCT05471128
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
An observational study of Prostate Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI). Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2023to Jan 2027
- 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 18 to 99 years
- Men only
- Adult, Older adult
Study population: The study population will cover all races, including socioeconomically disadvantaged minorities, that have been diagnosed with prostate cancer.
Who may be able to join
- Patients scheduled to undergo biopsy and with one of the following:
- Men with suspicion of prostate cancer
- Men on active surveillance
- Age ≥18 [30]
- Have available multiparametric prostate MRI
- Able to provide written, informed consent
- No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures
- Be willing and able to comply with scheduled visits
Who cannot join
- Previously confirmed prostate cancer diagnosis with Grade Group >= 2
- Unable to undergo prostate biopsy
- Prostate MRI unable to be evaluated using the PI-RADS v2 criteria
- Men with contraindication for MRI or a prostate biopsy
- Prostate biopsy within 8 weeks prior to mpMRI.
- Any history of prostate treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy for the Detection of Clinically Significant Prostate Cancer
The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).
Read the detailed description
This is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated PSA or abnormal digital rectal exam (DRE), or 2) known low-risk prostate cancer being managed with active surveillance.
Enrolled patients will undergo MRI fusion biopsy and standard-template 12 core TRUS biopsy as the standard-of-care. Patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. Detection rates of clinically significant lesions by ExactVu and by MRI will be compared.
- Conditions
- Prostate Cancer
- Being tested
- Standard of Care Biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care BiopsyProcedure or surgery
Patients will be evaluated with multiparametric MRI prostate followed by ExactVu micro-ultrasound to identify target lesions all of which will be biopsied by the examiner
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection Rate
To compare the detection rates of clinically significant prostate cancer lesions by ExactVu micro-ultrasound and by MRI-fusion
Measured: 2 years
Feasibility of ExactVu
To determine the feasibility of using ExactVu micro-ultrasounds to screen for prostate cancer in socioeconomically disadvantaged populations with limited access to care. Feasibility is measured by the percentage of patients that successfully undergo the study procedures.
Measured: 2 years
Secondary outcomes (2)
Predictive Performance Measures
To evaluate the sensitivity of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer
Measured: 2 years
Predictive Performance Measures
To evaluate the negative predictive value of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start27 Jan 2023
- Primary completion1 May 2025
- Study completionJan 2027 (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 University of OklahomaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew McIntosh, MD, Principal investigator, University of Oklahoma Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471128
- Sponsor's protocol ID
- OU-SCC-PROBX (P)
- Other IDs
- IRG-19-142-01
- Acronym
- OU-SCC-PROBX
- Status last verified
- Nov 2026
- First submitted
- 13 Jul 2022
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy for the Detection of Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT05471128
- Acronym / sponsor ID
- OU-SCC-PROBX / OU-SCC-PROBX (P)
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Jul 2022 (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.
The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).
Detailed description
This is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated PSA or abnormal digital rectal exam (DRE), or 2) known low-risk prostate cancer being managed with active surveillance.
Enrolled patients will undergo MRI fusion biopsy and standard-template 12 core TRUS biopsy as the standard-of-care. Patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. Detection rates of clinically significant lesions by ExactVu and by MRI will be compared.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- The study population will cover all races, including socioeconomically disadvantaged minorities, that have been diagnosed with prostate cancer.
Key inclusion criteria (8 listed)
- Patients scheduled to undergo biopsy and with one of the following:
- Age ≥18 [30]
- Have available multiparametric prostate MRI
- Able to provide written, informed consent
- No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures
Key exclusion criteria (6 listed)
- Previously confirmed prostate cancer diagnosis with Grade Group >= 2
- Unable to undergo prostate biopsy
- Prostate MRI unable to be evaluated using the PI-RADS v2 criteria
- Men with contraindication for MRI or a prostate biopsy
- Prostate biopsy within 8 weeks prior to mpMRI.
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 |
|---|---|---|
| Standard of Care BiopsyPatients will be evaluated with multiparametric MRI prostate followed by ExactVu micro-ultrasound to identify target lesions all of which will be biopsied by the examiner | Procedure or surgery | – |
Primary outcome
Detection Rate
Time frame: 2 years
To compare the detection rates of clinically significant prostate cancer lesions by ExactVu micro-ultrasound and by MRI-fusion
Feasibility of ExactVu
Time frame: 2 years
To determine the feasibility of using ExactVu micro-ultrasounds to screen for prostate cancer in socioeconomically disadvantaged populations with limited access to care. Feasibility is measured by the percentage of patients that successfully undergo the study procedures.
2 secondary outcomes
Predictive Performance Measures
Time frame: 2 years
Predictive Performance Measures
Time frame: 2 years
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 6 Nov 2026.
- 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.
Andrew McIntosh, MD principal investigator
University of Oklahoma Stephenson Cancer Center
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 Prostate Cancer, run by University of Oklahoma 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 8 inclusion and 6 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 6 Nov 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?
Detection Rate (time frame: 2 years). 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 6 Nov 2026.