NCT02871726 · Johns Hopkins University
Transrectal Ultrasound Robot-Assisted Prostate Biopsy
What this study is 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.
View original scientific description
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).
Interventions
DEVICE
TRUS-Robot
A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.
OTHER
TRUS biopsy
Uronav for prostate biopsy.
Primary outcome measures
Cancer Detection Rate of Clinically Significant Prostate Cancer
Time frame: 5 years
Number of biopsy patients diagnosed with Gleason score \>= 7 over the total number of patients on both arms of the study.
Investigational device serious adverse events
Time frame: 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
Time frame: 5 years
Number of biopsy patients diagnosed with Gleason score \<= 6 over the total number of patients on both arms of the study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Collaborators
National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations