Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Sponsors

Lead sponsor: Johns Hopkins University

Source Johns Hopkins University
Brief Summary

The commonly used diagnostic procedure for prostate cancer, a transrectal ultrasound (TRUS)-guided biopsy, has significant limitations. Freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. In addition, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Therefore, it is nearly impossible to re-biopsy or target the exact cancer foci. As a result, most TRUS-guided prostate biopsies today are poorly targeted and their spatial mapping remains subjective.

Detailed Description

This proposed feasibility and safety study of 5 patients attempts to improve TRUS-guided prostate biopsy by utilizing a novel robotic TRUS manipulator (TRUS Robot). A successful TRUS Robot guidance will provide crucial spatial information of the biopsy cores for improved prostate cancer detection, treatment, and monitoring. This proposed study is a proof of concept for a future protocol.

Overall Status Recruiting
Start Date January 2016
Completion Date August 2020
Primary Completion Date August 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of patients with treatment-related adverse events 1.5 years
Number of patients for whom the study-related procedures can be completed in less than 30 minutes 1.5 years
Enrollment 100
Condition
Intervention

Intervention type: Device

Intervention name: TRUS-Robot

Description: A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy

Arm group label: Experimental

Eligibility

Criteria:

Inclusion Criteria:

- Scheduled for an initial diagnostic biopsy

- Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam

Exclusion Criteria:

- Clinical diagnosis of prostate cancer

- Prior prostate biopsy

- Anal stenosis that prevents TRUS probe insertion

- Inadequate bowel prep

- Unwilling or unable to sign the informed consent

Gender: Male

Minimum age: 40 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Misop Han, M.D., M.S. Principal Investigator Johns Hopkins University
Overall Contact

Last name: Misop Han, M.D., M.S.

Phone: 410-614-9442

Email: [email protected]

Location
facility status contact Johns Hopkins Hospital Misop Han, M.D. 410-614-9442
Location Countries

United States

Verification Date

October 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Experimental

Arm group type: Experimental

Description: TRUS and TRUS-Robot will be used during prostate biopsy

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov