Clinical trial · Interventional
Transrectal Ultrasound Robot-Assisted Prostate Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRUS biopsy | Other | — | UNRESOLVED |
| TRUS-Robot | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TRUS-Robot and TRUS
- description
- TRUS and TRUS-Robot will be used during prostate biopsy
- interventionNames
- Device: TRUS-Robot
- Other: TRUS biopsy
- type
- ACTIVE_COMPARATOR
- label
- Routine TRUS/Fusion biopsy
- description
- Just Uronav will be used during prostate biopsy
- interventionNames
- Other: TRUS biopsy
Primary outcomes (3)
- measure
- Cancer Detection Rate of Clinically Significant Prostate Cancer
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available