RecruitingNot ApplicableNCT02871726

Transrectal Ultrasound Robot-Assisted Prostate Biopsy


Sponsor

Johns Hopkins University

Enrollment

483 participants

Start Date

Nov 24, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a robot-assisted device to help doctors perform prostate biopsies (taking a small tissue sample from the prostate) using ultrasound guidance, to see if the robot makes biopsies more accurate and safer. **You may be eligible if...** - You are scheduled for your first-ever prostate biopsy - You have a high PSA blood test result (above 4 ng/ml) — PSA is a protein that, when elevated, may suggest a prostate problem - Or your doctor found something unusual during a rectal exam **You may NOT be eligible if...** - You have already been diagnosed with prostate cancer - You have had a prostate biopsy before - You have anal narrowing that prevents an ultrasound probe from being inserted - You are unable or unwilling to sign the consent form - Your bowel was not properly prepared before the procedure Robotic assistance may improve accuracy in finding prostate cancer early. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETRUS-Robot

A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.

OTHERTRUS biopsy

Uronav for prostate biopsy.


Locations(1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

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NCT02871726


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