NCT07271017 · Johns Hopkins University
Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
What this study is about
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.
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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.
Interventions
DEVICE
Prostate biopsy
Precision personalized prostate biopsy with a novel ultrasound probe and robot, ProBot
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Where
- Baltimore, Maryland
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 8, 2025 · Source of record for eligibility and locations