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Clinical Trials/NCT02871726
NCT02871726
Recruiting
Not Applicable

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Johns Hopkins University1 site in 1 country483 target enrollmentNovember 24, 2021

Overview

Phase
Not Applicable
Intervention
TRUS-Robot
Conditions
Prostate Cancer
Sponsor
Johns Hopkins University
Enrollment
483
Locations
1
Primary Endpoint
Investigational device serious adverse events
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).

Detailed Description

This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.

Registry
clinicaltrials.gov
Start Date
November 24, 2021
End Date
August 1, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

TRUS-Robot and TRUS

TRUS and TRUS-Robot will be used during prostate biopsy

Intervention: TRUS-Robot

TRUS-Robot and TRUS

TRUS and TRUS-Robot will be used during prostate biopsy

Intervention: TRUS biopsy

Routine TRUS/Fusion biopsy

Just Uronav will be used during prostate biopsy

Intervention: TRUS biopsy

Outcomes

Primary Outcomes

Investigational device serious adverse events

Time Frame: 5 years

Serious adverse events will be assessed according to 21 Code of Federal Regulations (CFR) Part 812.3(s).

Cancer Detection Rate of Clinically Significant Prostate Cancer

Time Frame: 5 years

Number of biopsy patients diagnosed with Gleason score \>= 7 over the total number of patients on both arms of the study.

Cancer Detection Rate of Clinically Insignificant Prostate Cancer

Time Frame: 5 years

Number of biopsy patients diagnosed with Gleason score \<= 6 over the total number of patients on both arms of the study.

Secondary Outcomes

  • Predictive rates of detecting clinically significant prostate cancer at biopsy(5 years)
  • Needle targeting accuracy(5 years)
  • Procedure time(Up to 30 minutes)
  • Sensitivity of detecting clinically significant prostate cancer at biopsy(5 years)
  • Specificity of detecting clinically significant prostate cancer at biopsy(5 years)

Study Sites (1)

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