Transrectal Ultrasound Robot-Assisted Prostate Biopsy
- Conditions
- Prostate Cancer
- Interventions
- Other: TRUS biopsyDevice: TRUS-Robot
- Registration Number
- NCT02871726
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 483
- Scheduled for an initial diagnostic biopsy
- Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine TRUS/Fusion biopsy TRUS biopsy Just Uronav will be used during prostate biopsy TRUS-Robot and TRUS TRUS-Robot TRUS and TRUS-Robot will be used during prostate biopsy TRUS-Robot and TRUS TRUS biopsy TRUS and TRUS-Robot will be used during prostate biopsy
- Primary Outcome Measures
Name Time Method Investigational device serious adverse events 5 years Serious adverse events will be assessed according to 21 Code of Federal Regulations (CFR) Part 812.3(s).
Cancer Detection Rate of Clinically Insignificant Prostate Cancer 5 years Number of biopsy patients diagnosed with Gleason score \<= 6 over the total number of patients on both arms of the study.
Cancer Detection Rate of Clinically Significant Prostate Cancer 5 years Number of biopsy patients diagnosed with Gleason score \>= 7 over the total number of patients on both arms of the study.
- Secondary Outcome Measures
Name Time Method Procedure time Up to 30 minutes The time of the actual biopsy procedure measured in minutes.
Predictive rates of detecting clinically significant prostate cancer at biopsy 5 years Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate predictive rates.
Needle targeting accuracy 5 years Needle targeting errors will be measured as the distance between the planned core center and the inserted needle axis. Targeting accuracy will be calculated as the average of the needle targeting errors, as usual.
Sensitivity of detecting clinically significant prostate cancer at biopsy 5 years Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate sensitivity.
Specificity of detecting clinically significant prostate cancer at biopsy 5 years Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate specificity.
Trial Locations
- Locations (1)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States