Transrectal Ultrasound Robot-Assisted Prostate Biopsy
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 11/7/2018 |
| Start Date: | January 2016 |
| End Date: | October 2019 |
| Contact: | Misop Han, M.D., M.S. |
| Email: | mhan1@jhmi.edu |
| Phone: | 410-614-9442 |
The commonly used diagnostic procedure for prostate cancer, a transrectal ultrasound
(TRUS)-guided biopsy, has significant limitations. Freehand biopsy cores are often spatially
clustered, rather than uniformly distributed, and do not accurately follow the recommended,
sextant template. In addition, a freehand TRUS-guided biopsy does not allow precise mapping
of the biopsy cores within the prostate. Therefore, it is nearly impossible to re-biopsy or
target the exact cancer foci. As a result, most TRUS-guided prostate biopsies today are
poorly targeted and their spatial mapping remains subjective.
(TRUS)-guided biopsy, has significant limitations. Freehand biopsy cores are often spatially
clustered, rather than uniformly distributed, and do not accurately follow the recommended,
sextant template. In addition, a freehand TRUS-guided biopsy does not allow precise mapping
of the biopsy cores within the prostate. Therefore, it is nearly impossible to re-biopsy or
target the exact cancer foci. As a result, most TRUS-guided prostate biopsies today are
poorly targeted and their spatial mapping remains subjective.
This proposed feasibility and safety study of 5 patients attempts to improve TRUS-guided
prostate biopsy by utilizing a novel robotic TRUS manipulator (TRUS Robot). A successful TRUS
Robot guidance will provide crucial spatial information of the biopsy cores for improved
prostate cancer detection, treatment, and monitoring. This proposed study is a proof of
concept for a future protocol.
prostate biopsy by utilizing a novel robotic TRUS manipulator (TRUS Robot). A successful TRUS
Robot guidance will provide crucial spatial information of the biopsy cores for improved
prostate cancer detection, treatment, and monitoring. This proposed study is a proof of
concept for a future protocol.
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
We found this trial at
1
site
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
Click here to add this to my saved trials
