Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age40-75
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men between the ages of 40 and 75

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prostate biopsy

    Device

    Precision personalized prostate biopsy with a novel ultrasound probe and robot, ProBot

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Transrectal biopsy (TR)Experimental treatment 1 intervention
Group B: Transperineal biopsy (TP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Device feasibility as assessed by patient discomfort score

Scale 1-10, 10 highest discomfort

Time frame
Immediately after the procedure
2

Device feasibility as assessed by maximal procedural pain

Scale 1-10, 10 highest pain

Time frame
Immediately after the procedure
3

Device feasibility as assessed by the rate of complications

Rate of complications

Time frame
Throughout the study, each case recorded within 1 month of the procedure
4

Device feasibility as assessed by serious adverse events

Serious Adverse events throughout the study

Time frame
Up to 1 month post procedure

Secondary outcomes

1

Prostate cancer detection rates at targeted biopsy (TB)

Clinically significant PCa detection rates at TB throughout the study

Time frame
Up to 1 month post procedure
2

Prostate cancer detection rates at systematic biopsy (SB)

Clinically significant PCa detection rates at SB throughout the study

Time frame
Up to one month post procedure
3

Needle targeting errors

Measured in ultrasound throughout the study

Time frame
Immediately post procedure
4

Prostate deformations (mm)

Maximum deformation of the gland between the start and end of the procedure measured in \[mm\] throughout the study

Time frame
Immediately post procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Cancer Institute (NCI)

Collaborator