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

Use our guide to learn which trials are right for you!

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.

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.

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
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: 410-614-9442
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials