Prostate Cancer Clinical Trial

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

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).

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Full Description

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.

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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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

483

Study ID:

NCT02871726

Recruitment Status:

Recruiting

Sponsor:

Johns Hopkins University

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There is 1 Location for this study

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Johns Hopkins Hospital
Baltimore Maryland, 21287, United States More Info
Misop Han, M.D.
Contact
410-614-9442

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

483

Study ID:

NCT02871726

Recruitment Status:

Recruiting

Sponsor:


Johns Hopkins University

How clear is this clinincal trial information?

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