Clinical trial · Observational
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
NCT03679819CI-TRIAL-00040869EXACTVUunknownClinicalTrials.gov clinicaltrialsProvenance
- 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 primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HR-TRUS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HR-TRUS
- description
- HR-TRUS for the detection of prostate cancer in men scheduled for radical prostatectomy for localized prostate cancer
- interventionNames
- Device: HR-TRUS
Primary outcomes (1)
- measure
- Diagnostic accuracy of high resolution ultrasound
- timeFrame
- From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
- description
- rate of adequately identified (positive or negative) lesions of prostate cancer
Secondary outcomes (4)
- measure
- Precisions of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer.
- timeFrame
- From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. men \> 35 years age and \<80 years of age 2. diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy 3. staging by standard procedures show localized disease (\<cT4) 4. PSA \< 50ng/ml 5. Access to the rectum for trans rectal ultrasound 6. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen 7. Signed written informed consent prior to any screening procedures being performed Exclusion Criteria: 1. Patient with absence of diagnosis of prostate cancer 2. Patient with metastatic prostate cancer 3. Patient with rectal amputation 4. Patient with contraindications for MRI 5. Patient in urgency situation, adult under legal protection, or unable to give his consent.
References
Publications (5)
- BACKGROUNDPavlovich CP, Cornish TC, Mullins JK, Fradin J, Mettee LZ, Connor JT, Reese AC, Askin FB, Luck R, Epstein JI, Burke HB. High-resolution transrectal ultrasound: pilot study of a novel technique for imaging clinically localized prostate cancer. Urol Oncol. 2014 Jan;32(1):34.e27-32. doi: 10.1016/j.urolonc.2013.01.006. Epub 2013 Apr 2. PMID 23558161
- BACKGROUNDWalz J, Marcy M, Maubon T, Brunelle S, Laroche J, Gravis G, Salem N, Bladou F. [Real time elastography in the diagnosis of prostate cancer: comparison of preoperative imaging and histology after radical prostatectomy]. Prog Urol. 2011 Dec;21(13):925-31. doi: 10.1016/j.purol.2011.04.006. Epub 2011 Jun 2. French. PMID 22118357
- BACKGROUNDGhai S, Eure G, Fradet V, Hyndman ME, McGrath T, Wodlinger B, Pavlovich CP. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016 Aug;196(2):562-9. doi: 10.1016/j.juro.2015.12.093. Epub 2016 Jan 12. PMID 26791931
- BACKGROUNDBoehm K, Salomon G, Beyer B, Schiffmann J, Simonis K, Graefen M, Budaeus L. Shear wave elastography for localization of prostate cancer lesions and assessment of elasticity thresholds: implications for targeted biopsies and active surveillance protocols. J Urol. 2015 Mar;193(3):794-800. doi: 10.1016/j.juro.2014.09.100. Epub 2014 Sep 28. PMID 25264337
- BACKGROUNDVillers A, Puech P, Mouton D, Leroy X, Ballereau C, Lemaitre L. Dynamic contrast enhanced, pelvic phased array magnetic resonance imaging of localized prostate cancer for predicting tumor volume: correlation with radical prostatectomy findings. J Urol. 2006 Dec;176(6 Pt 1):2432-7. doi: 10.1016/j.juro.2006.08.007. PMID 17085122