Clinical trial NCT02871726: Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Official title: Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer Detection
Prostate Biopsy
Prostate Cancer
Transrectal Ultrasound
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-08-18
Enrollment: 483
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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.

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

Primary outcomes:
measure: Cancer Detection Rate of Clinically Significant Prostate Cancer
timeFrame: 5 years
measure: Investigational device serious adverse events
timeFrame: 5 years
measure: Cancer Detection Rate of Clinically Insignificant Prostate Cancer
timeFrame: 5 years
Secondary outcomes:
measure: Needle targeting accuracy
timeFrame: 5 years
measure: Procedure time
timeFrame: Up to 30 minutes
measure: Sensitivity of detecting clinically significant prostate cancer at biopsy
timeFrame: 5 years
measure: Specificity of detecting clinically significant prostate cancer at biopsy
timeFrame: 5 years
measure: Predictive rates of detecting clinically significant prostate cancer at biopsy
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Misop Han, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: