Prostate Cancer (Diagnosis)Phase 1NCT07271017
Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
A Phase 1 study testing Prostate biopsy in people with Prostate Cancer (Diagnosis), run by Johns Hopkins University at 1 site in United States.
Trial summary
Prostate cancer (PCa) is the most diagnosed type of cancer and the second leading cause of cancer related deaths among US men, and its incidence has increased steadily in the last decade. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis)
- What is being tested?
- Prostate biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2025to 31 May 2030
- Phase
- Phase 1
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Included in the study will be:
- Men between the ages of 40 and 75
- Men must have one of the following "high risk" features:
- PSA > 4.0 ng/ml and/or abnormal digital rectal examination (DRE)
- ASAP (atypical small acinar proliferation) on previous biopsy
- Men with mpMRI or bpMRI exams, including both PI-RADS ≤2 and PI-RADS ≥3.
Excluded from the study will be patients without available mpMRI exams and patients:
- Females and children because of the prostate cancer targeted disease.
- Patients who are not recommended or in whom TR or TP prostate biopsy is considered high-risk:
- Patients with previous rectal surgery.
- Patients with anal stenosis or coagulopathy.
- Patients on active anticoagulation medication (eg. Coumadin, Lovenox, or Heparin).
- Patients who cannot tolerate periprostatic Lidocaine block anesthesia or in whom anesthesia is considered high-risk.
- Patients who already had a prostate biopsy taken with the ProBot investigational device.
- Vulnerable populations, such as prisoners, institutionalized individuals.
- Patients who are unwilling or unable to sign informed consent (no assent required).
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
Rana Harb, 410-502-5500, rharb1@jhmi.edu
Sara A Naizghi, 720-965-9494, snaizgh1@jh.edu
About this study
Prostate cancer (PCa) is the most diagnosed type of cancer and the second leading cause of cancer related deaths among US men, and its incidence has increased steadily in the last decade. Efforts to address the rise in PCa diagnosis without overdetection and overtreatment include targeted biopsy techniques for clinically significant PCa using magnetic resonance imaging (MRI), and precision targeted biopsy guided by ultrasound and fused to the MRI.
The study aims to improve prostate biopsy with a novel ultrasound probe and robot developed at Johns Hopkins, the ProBot device. The trial is a Phase 1 clinical trial to evaluate the safety and feasibility of the new device.
Read more
ProBot is an entirely new concept including a novel ultrasound probe and robot kinematics specifically designed for the prostate. It operates with only two degrees of freedom configured such that the motions for 3D image scanning and biopsy may not deform the prostate gland, thus improving the accuracy of MRI-ultrasound fusion and needle targeting at biopsy.
ProBot is a small and lightweight robot (1.3Kg including the ultrasound probe). It allows hands-free operation of its ultrasound probe at 3D image scanning and needle targeting supervised by the urologist.
In addition to MRI-targeted biopsy (TB), at systematic biopsy (SB), instead of using the common template plan that is the same for all patients, the innovative software optimizes the plan for each patient to obtain a diagnosis that is representative of the whole gland histology. The ProBot robot is also uniquely capable of transrectal (TR) and transperineal (TP) biopsy.
The aims of the study are to determine the safety and feasibility of the new device at TR and TP biopsies.
- Conditions
- Prostate Cancer (Diagnosis)
- Being tested
- Prostate biopsy
- Keywords
- Robot biopsy, Fusion biopsy, MRI targeted biopsy, Systematic biopsy, Personalized biopsy, Precision biopsy, Biopsy optimization
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate biopsyDevice
Precision personalized prostate biopsy with a novel ultrasound probe and robot, ProBot
| Study group | Role | What they receive |
|---|---|---|
| Transrectal biopsy (TR) | Experimental | Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transrectal path Receives: Device: Prostate biopsy |
| Transperineal biopsy (TP) | Experimental | Biopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transperineal path. Receives: Device: Prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device feasibility as assessed by patient discomfort score
Scale 1-10, 10 highest discomfort
Measured: Immediately after the procedure
Device feasibility as assessed by maximal procedural pain
Scale 1-10, 10 highest pain
Measured: Immediately after the procedure
Device feasibility as assessed by the rate of complications
Rate of complications
Measured: Throughout the study, each case recorded within 1 month of the procedure
Device feasibility as assessed by serious adverse events
Serious Adverse events throughout the study
Measured: Up to 1 month post procedure
Device feasibility as assessed by the rate of successful completion of cases
Rate of cases completed successfully throughout the study
Measured: Immediately post procedure
Device feasibility as assessed by the procedure time
Times of the procedures measured in minutes throughout the study
Measured: Immediately post procedure
Secondary outcomes (5)
Prostate cancer detection rates at targeted biopsy (TB)
Clinically significant PCa detection rates at TB throughout the study
Measured: Up to 1 month post procedure
Prostate cancer detection rates at systematic biopsy (SB)
Clinically significant PCa detection rates at SB throughout the study
Measured: Up to one month post procedure
Needle targeting errors
Measured in ultrasound throughout the study
Measured: Immediately post procedure
Prostate deformations (mm)
Maximum deformation of the gland between the start and end of the procedure measured in [mm] throughout the study
Measured: Immediately post procedure
Prostate displacement (mm)
Displacement of the gland between the start and end of the procedure measured in [mm] throughout the study
Measured: Immediately post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start23 Sep 2025
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies 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 1
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients are enrolled consecutively in the TR or TP biopsy groups by the urologists and accounting for patient's preference
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Misop Han, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271017
- Sponsor's protocol ID
- IRB00229568
- Other IDs
- R01CA303859
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
- ClinicalTrials.gov ID
- NCT07271017
- Acronym / sponsor ID
- IRB00229568
- Conditions
- Prostate Cancer (Diagnosis)
- Keywords
- Robot biopsy, Fusion biopsy, MRI targeted biopsy, Systematic biopsy, Personalized biopsy, Precision biopsy, Biopsy optimization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 8 Dec 2025 (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.
Prostate cancer (PCa) is the most diagnosed type of cancer and the second leading cause of cancer related deaths among US men, and its incidence has increased steadily in the last decade. Efforts to address the rise in PCa diagnosis without overdetection and overtreatment include targeted biopsy techniques for clinically significant PCa using magnetic resonance imaging (MRI), and precision targeted biopsy guided by ultrasound and fused to the MRI.
The study aims to improve prostate biopsy with a novel ultrasound probe and robot developed at Johns Hopkins, the ProBot device. The trial is a Phase 1 clinical trial to evaluate the safety and feasibility of the new device.
ProBot is an entirely new concept including a novel ultrasound probe and robot kinematics specifically designed for the prostate. It operates with only two degrees of freedom configured such that the motions for 3D image scanning and biopsy may not deform the prostate gland, thus improving the accuracy of MRI-ultrasound fusion and needle targeting at biopsy.
ProBot is a small and lightweight robot (1.3Kg including the ultrasound probe). It allows hands-free operation of its ultrasound probe at 3D image scanning and needle targeting supervised by the urologist.
In addition to MRI-targeted biopsy (TB), at systematic biopsy (SB), instead of using the common template plan that is the same for all patients, the innovative software optimizes the plan for each patient to obtain a diagnosis that is representative of the whole gland histology. The ProBot robot is also uniquely capable of transrectal (TR) and transperineal (TP) biopsy.
The aims of the study are to determine the safety and feasibility of the new device at TR and TP biopsies.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are enrolled consecutively in the TR or TP biopsy groups by the urologists and accounting for patient's preference
| Arm | Type | Receives |
|---|---|---|
| Transrectal biopsy (TR) | Experimental | Device: Prostate biopsyBiopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transrectal path |
| Transperineal biopsy (TP) | Experimental | Device: Prostate biopsyBiopsy guided by transrectal ultrasound fused with MRI and needle inserted on a transperineal path. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Prostate biopsyPrecision personalized prostate biopsy with a novel ultrasound probe and robot, ProBot | Device | Transperineal biopsy (TP), Transrectal biopsy (TR) |
Primary outcome
Device feasibility as assessed by patient discomfort score
Time frame: Immediately after the procedure
Scale 1-10, 10 highest discomfort
Device feasibility as assessed by maximal procedural pain
Time frame: Immediately after the procedure
Scale 1-10, 10 highest pain
Device feasibility as assessed by the rate of complications
Time frame: Throughout the study, each case recorded within 1 month of the procedure
Rate of complications
Device feasibility as assessed by serious adverse events
Time frame: Up to 1 month post procedure
Serious Adverse events throughout the study
Device feasibility as assessed by the rate of successful completion of cases
Time frame: Immediately post procedure
Rate of cases completed successfully throughout the study
Device feasibility as assessed by the procedure time
Time frame: Immediately post procedure
Times of the procedures measured in minutes throughout the study
5 secondary outcomes
Prostate cancer detection rates at targeted biopsy (TB)
Time frame: Up to 1 month post procedure
Prostate cancer detection rates at systematic biopsy (SB)
Time frame: Up to one month post procedure
Needle targeting errors
Time frame: Immediately post procedure
Prostate deformations (mm)
Time frame: Immediately post procedure
Prostate displacement (mm)
Time frame: Immediately post procedure
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 8 Dec 2025.
- 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, MD 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 Phase 1 study testing Prostate biopsy in people with Prostate Cancer (Diagnosis), 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?
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 8 Dec 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rana Harb (410-502-5500, rharb1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device feasibility as assessed by patient discomfort score (time frame: Immediately after the procedure). The study lists 6 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 8 Dec 2025.