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Recruiting
NCT02871726
Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Conditions: Prostate Cancer
Sex: Male
Ages: 45 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 483
Sponsor: Johns Hopkins University
Location: Johns Hopkins Hospital Baltimore Maryland
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).
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
Source: ClinicalTrials.gov (NCT02871726). StuddyBuddy aggregates publicly available trial information.