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NCT07271017 · ClinicalTrials.gov registry record · Phase 1
Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
A Phase 1 study of Prostate Cancer (Diagnosis), sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07271017: Recruiting Phase 1 study of Prostate Cancer (Diagnosis), sponsored by Johns Hopkins University.
NCT07271017 is a Phase 1 study of Prostate Cancer (Diagnosis) that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 60 participants, below the 872-participant average among 5 other Prostate Cancer (Diagnosis) trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07271017, a Phase 1 study of Prostate Cancer (Diagnosis), is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
Scale 1-10, 10 highest discomfort
Conditions Studied
Interventions
- DEVICE Prostate biopsy
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-09-23 |
| Est. Completion | 2030-05-31 |
| Phase | Phase 1 |
What NCT07271017 shows while recruiting
NCT07271017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 872-participant average among 5 other Prostate Cancer (Diagnosis) trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Prostate Cancer (Diagnosis) appearing as the primary indexed condition, and to 1 intervention - of which Prostate biopsy is the first listed.
NCT07271017 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07271017 about?
NCT07271017 is a clinical study titled "Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe". 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 tec...
What is the current status of trial NCT07271017?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2025-09-23. Estimated completion is 2030-05-31.
What conditions does trial NCT07271017 study?
This clinical trial studies the following conditions: Prostate Cancer (Diagnosis).
What interventions are being tested in trial NCT07271017?
The interventions under investigation include: Prostate biopsy (DEVICE).
Who is sponsoring clinical trial NCT07271017?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07271017 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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