Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Johns Hopkins University

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: TRUS biopsy; Device: TRUS-Robot

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02871726

IRB00068488

Details and patient eligibility

About

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).

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.

Enrollment: 483 estimated patients

Sex: Male

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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483 participants in 2 patient groups

TRUS-Robot and TRUS

Experimental group

Description:

TRUS and TRUS-Robot will be used during prostate biopsy

Treatment:

Device: TRUS-Robot

Other: TRUS biopsy

Routine TRUS/Fusion biopsy

Active Comparator group

Description:

Just Uronav will be used during prostate biopsy

Treatment:

Other: TRUS biopsy