Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Misop Han, M.D.
- 410-614-9442
Principal Investigator
- Misop Han, M.D., M.S.
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
Study Plan
TRUS-Robot and TRUS
EXPERIMENTAL
TRUS and TRUS-Robot will be used during prostate biopsy
DEVICE:
TRUS-RobotDescription:
A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.OTHER:
TRUS biopsyDescription:
Uronav for prostate biopsy.
Routine TRUS/Fusion biopsy
ACTIVE_COMPARATOR
Just Uronav will be used during prostate biopsy
OTHER:
TRUS biopsyDescription:
Uronav for prostate biopsy.
Outcome Measures
Primary Outcome Measures
Cancer Detection Rate of Clinically Significant Prostate Cancer
Investigational device serious adverse events
Cancer Detection Rate of Clinically Insignificant Prostate Cancer
Secondary Outcome Measures
Needle targeting accuracy
Procedure time
Sensitivity of detecting clinically significant prostate cancer at biopsy
Specificity of detecting clinically significant prostate cancer at biopsy
Predictive rates of detecting clinically significant prostate cancer at biopsy
Timeline
Last Updated
February 13, 2024Start Date
August 18, 2016Today
February 5, 2025Completion Date ( Estimated )
August 1, 2026
Sponsors of this trial
Lead Sponsor
Johns Hopkins UniversityCollaborating Sponsors
National Institutes of Health (NIH)