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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Prostate biopsy
DevicePrecision personalized prostate biopsy with a novel ultrasound probe and robot, ProBot
Treatment groups
Trial outcomes
Primary outcomes
Device feasibility as assessed by patient discomfort score
Scale 1-10, 10 highest discomfort
Device feasibility as assessed by maximal procedural pain
Scale 1-10, 10 highest pain
Device feasibility as assessed by the rate of complications
Rate of complications
Device feasibility as assessed by serious adverse events
Serious Adverse events throughout the study
Secondary outcomes
Prostate cancer detection rates at targeted biopsy (TB)
Clinically significant PCa detection rates at TB throughout the study
Prostate cancer detection rates at systematic biopsy (SB)
Clinically significant PCa detection rates at SB throughout the study
Needle targeting errors
Measured in ultrasound throughout the study
Prostate deformations (mm)
Maximum deformation of the gland between the start and end of the procedure measured in \[mm\] throughout the study
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Cancer Institute (NCI)
Collaborator