Clinical trial · Interventional
Urology of Virginia Case Series
- 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)
The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer. The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI). These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy. In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the PROSTATE | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-resolution micro-ultrasound guided prostate biopsy | Device | — | UNRESOLVED |
| mpMRI guided prostate examination using PI-RADS v2 | Device | — | UNRESOLVED |
| Ultrasound guided prostate exam using SOC ultrasound system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Micro-ultrasound
- description
- Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities: * Low resolution transrectal ultrasound examination ("LR-TRUS") * Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol
- interventionNames
- Device: Ultrasound guided prostate exam using SOC ultrasound system
- Device: mpMRI guided prostate examination using PI-RADS v2
- Device: High-resolution micro-ultrasound guided prostate biopsy
Primary outcomes (1)
- measure
- Keyword Description of Each Biopsy Sample
- timeFrame
- For each patient, keywords will be assigned within one week following the patient's procedure.
- description
- The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. All men ≥ 40 years age and \<80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer. 2. PSA\<50 3. Clinical stage \< cT2c Exclusion Criteria: Patients will be excluded from being included in the investigation if any of the following is true: 1. Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia 2. Men with known prostate volume (from prior imaging) of \> 60cc 3. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy 4. Men who are unable to provide their own informed consent 5. Men who have contraindications to MRI or gadolinium chelate contrast
References
Publications (0)
Data not yet available