Clinical trial · Interventional
Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer
- 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)
This trial uses a ultra high-resolution ultrasound system and specialized transducer, intended for use in prostate imaging. The system's image resolution is significantly better than the standard of care, due to its higher frequency. This allows the system to visualize suspicious areas and structures, and for greater accuracy for guided biopsy. The primary objective of this study is to demonstrate that ultra high-resolution transrectal ultrasound (UHR-TRUS) is superior to conventional low-resolution transrectal ultrasound (LR-TRUS) in detecting clinically significant cancer among men without known prostate cancer and with an indication for prostate biopsy. The secondary objective of this study is to compare the difference in the rate of detection of clinically significant cancer between LR-TRUS and UHR-TRUS, from before investigator training to after investigator training. The tertiary objective for the investigation is to compare the combined sensitivity and specificity in determining cancer detection overall for image-guided biopsy in UHR-TRUS vs. LR-TRUS.
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 Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-resolution ultrasound guided prostate biopsy | Device | — | UNRESOLVED |
| Standard ultrasound guided prostate biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LR-TRUS
- description
- Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)
- interventionNames
- Device: Standard ultrasound guided prostate biopsy
- type
- EXPERIMENTAL
- label
- UHR-TRUS
- description
- Ultra-high resolution transrectal ultrasound guided prostate biopsy
- interventionNames
- Device: High-resolution ultrasound guided prostate biopsy
Primary outcomes (1)
- measure
- Percentage of Participants With Clinically Significant Prostate Cancer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * All men \> 40 years age and \<80 years of age with 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). * PSA\<50 * Clinical stage \< cT3 Exclusion Criteria: * Men with a history of prostate cancer * Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia * Men with known prostate volume (from prior imaging) of \> 60cc * Men with anorectal abnormalities preventing TRUS-guided prostate biopsy * Men who are unable to provide their own informed consent
References
Publications (1)
- DERIVEDRohrbach D, Wodlinger B, Wen J, Mamou J, Feleppa E. High-Frequency Quantitative Ultrasound for Imaging Prostate Cancer Using a Novel Micro-Ultrasound Scanner. Ultrasound Med Biol. 2018 Jul;44(7):1341-1354. doi: 10.1016/j.ultrasmedbio.2018.02.014. Epub 2018 Apr 4. PMID 29627083