Transrectal Ultrasound Robot-Assisted Prostate Biopsy
About This Trial
- This study is testing whether a robotic system can help doctors take tissue samples from the prostate more accurately than standard biopsy techniques.
- It is open to men who are scheduled for their very first prostate biopsy because of an abnormal physical exam or a high PSA blood test result.
- You cannot participate if you have already had a prostate biopsy or have previously been diagnosed with prostate cancer.
- Before joining, patients should know that the procedure uses an ultrasound probe placed into the rectum and requires special preparation to clean out the bowels beforehand.
More Information
- 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).
Who Can Enroll
- Age Range: 45 - 75 years
- Gender: Male
- Who This Trial is For: This study is testing whether a robotic system can help doctors take tissue samples from the prostate more accurately than standard biopsy techniques.
Study Details
- Start Date: November 24, 2021
- Lead Sponsor: Johns Hopkins University
Full 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
Treatments
- Device: TRUS-Robot
- Other: TRUS biopsy