Johns Hopkins University
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).
Prostate Cancer
TRUS-Robot
TRUS biopsy
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 483 participants |
| Masking : | NONE |
| Primary Purpose : | DIAGNOSTIC |
| Official Title : | Transrectal Ultrasound Robot-Assisted Prostate Biopsy |
| Actual Study Start Date : | 2021-11-24 |
| Estimated Primary Completion Date : | 2026-08 |
| Estimated Study Completion Date : | 2026-08 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 45 Years to 75 Years |
| Sexes Eligible for Study: | MALE |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287