NCT02871726 Transrectal Ultrasound Robot-Assisted Prostate Biopsy
| NCT ID | NCT02871726 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 483 participants |
| Start Date | 2021-11-24 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 483 participants in total. It began in 2021-11-24 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Misop Han, M.D., M.S.
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT02871726 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 75 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02871726 currently recruiting?
Yes, NCT02871726 is actively recruiting participants. Contact the research team at mhan1@jhmi.edu for enrollment information.
Where is the NCT02871726 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT02871726 clinical trial?
NCT02871726 is sponsored by Johns Hopkins University. The principal investigator is Misop Han, M.D., M.S. at Johns Hopkins University. The trial plans to enroll 483 participants.
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