Prostate CancerNCT02871726
Transrectal Ultrasound Robot-Assisted Prostate Biopsy
A study testing TRUS-Robot and TRUS biopsy in people with Prostate Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TRUS-Robot and TRUS biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2021to Aug 2029
- 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 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for an initial diagnostic biopsy
- Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam
Who cannot join
- Clinical diagnosis of prostate cancer
- Prior prostate biopsy
- Anal stenosis that prevents TRUS probe insertion
- Inadequate bowel prep
- Unwilling or unable to sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Misop Han, M.D., 410-614-9442
About this study
Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).
Read the detailed description
This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.
- Conditions
- Prostate Cancer
- Being tested
- TRUS-Robot, TRUS biopsy
- Keywords
- Prostate Cancer Detection, Prostate Biopsy, Prostate Cancer, Transrectal Ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUS-RobotDevice
A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.
TRUS biopsyOther
Uronav for prostate biopsy.
| Study group | Role | What they receive |
|---|---|---|
| TRUS-Robot and TRUS | Experimental | TRUS and TRUS-Robot will be used during prostate biopsy Receives: Device: TRUS-Robot; Other: TRUS biopsy |
| Routine TRUS/Fusion biopsy | Active comparator | Just Uronav will be used during prostate biopsy Receives: Other: TRUS biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection Rate of Clinically Significant Prostate Cancer
Number of biopsy patients diagnosed with Gleason score >= 7 over the total number of patients on both arms of the study.
Measured: 5 years
Investigational device serious adverse events
Serious adverse events will be assessed according to 21 Code of Federal Regulations (CFR) Part 812.3(s).
Measured: 5 years
Cancer Detection Rate of Clinically Insignificant Prostate Cancer
Number of biopsy patients diagnosed with Gleason score <= 6 over the total number of patients on both arms of the study.
Measured: 5 years
Secondary outcomes (5)
Needle targeting accuracy
Needle targeting errors will be measured as the distance between the planned core center and the inserted needle axis. Targeting accuracy will be calculated as the average of the needle targeting errors, as usual.
Measured: 5 years
Procedure time
The time of the actual biopsy procedure measured in minutes.
Measured: Up to 30 minutes
Sensitivity of detecting clinically significant prostate cancer at biopsy
Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate sensitivity.
Measured: 5 years
Specificity of detecting clinically significant prostate cancer at biopsy
Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate specificity.
Measured: 5 years
Predictive rates of detecting clinically significant prostate cancer at biopsy
Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate predictive rates.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start24 Nov 2021
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (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 Johns Hopkins 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
- 483 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Misop Han, M.D., M.S., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871726
- Sponsor's protocol ID
- IRB00068488
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2016
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transrectal Ultrasound Robot-Assisted Prostate Biopsy
- ClinicalTrials.gov ID
- NCT02871726
- Acronym / sponsor ID
- IRB00068488
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer Detection, Prostate Biopsy, Prostate Cancer, Transrectal Ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 483 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 18 Aug 2016 (estimated)
- 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.
Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).
Detailed description
This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRUS-Robot and TRUS | Experimental | Device: TRUS-Robot, Other: TRUS biopsyTRUS and TRUS-Robot will be used during prostate biopsy |
| Routine TRUS/Fusion biopsy | Active comparator | Other: TRUS biopsyJust Uronav will be used during prostate biopsy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for an initial diagnostic biopsy
- Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam
Key exclusion criteria (5 listed)
- Clinical diagnosis of prostate cancer
- Prior prostate biopsy
- Anal stenosis that prevents TRUS probe insertion
- Inadequate bowel prep
- Unwilling or unable to sign the informed 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 |
|---|---|---|
| TRUS-RobotA robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy. | Device | TRUS-Robot and TRUS |
| TRUS biopsyUronav for prostate biopsy. | Other | Routine TRUS/Fusion biopsy, TRUS-Robot and TRUS |
Primary outcome
Cancer Detection Rate of Clinically Significant Prostate Cancer
Time frame: 5 years
Number of biopsy patients diagnosed with Gleason score >= 7 over the total number of patients on both arms of the study.
Investigational device serious adverse events
Time frame: 5 years
Serious adverse events will be assessed according to 21 Code of Federal Regulations (CFR) Part 812.3(s).
Cancer Detection Rate of Clinically Insignificant Prostate Cancer
Time frame: 5 years
Number of biopsy patients diagnosed with Gleason score <= 6 over the total number of patients on both arms of the study.
5 secondary outcomes
Needle targeting accuracy
Time frame: 5 years
Procedure time
Time frame: Up to 30 minutes
Sensitivity of detecting clinically significant prostate cancer at biopsy
Time frame: 5 years
Specificity of detecting clinically significant prostate cancer at biopsy
Time frame: 5 years
Predictive rates of detecting clinically significant prostate cancer at biopsy
Time frame: 5 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 26 Aug 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.
Misop Han, M.D., M.S. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUS-Robot and TRUS biopsy in people with Prostate Cancer, run by Johns Hopkins 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 5 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 26 Aug 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?
Contact Misop Han, M.D., M.S. (410-614-9442, mhan1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Detection Rate of Clinically Significant Prostate Cancer (time frame: 5 years). The study lists 3 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 26 Aug 2026.