Clinical trial · Interventional
Study of Current Practice Which Compare the Rate of Prostate Cancer by Using 2 Kind of Transrectal Biopsies: 3 by IRM-echography Image Fusion and 12 Systematized Guided Echographies.
Comparison of Prostate Cancer Detection Rates Obtained With Multiparametric MRI Targeted Transrectal Ultrasound Biopsies and Systematic Transrectal Ultrasound Biopsies.
NCT02050542CI-TRIAL-00097587MURIELLEcompletedN/AClinicalTrials.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 purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate.
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 |
|---|---|---|---|
| systematic biopsies | Procedure | — | UNRESOLVED |
| Targeted biopsies guided by a fusion of MRI and ultrasound- images | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Targeted biopsies guided by a fusion of MRI and ultrasound
- description
- After the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system
- interventionNames
- Procedure: systematic biopsies
- Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images
- type
- OTHER
- label
- Systematic biopsies
- description
- The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
- interventionNames
- Procedure: systematic biopsies
- Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * patient from 45 to 75 years old; * Serum level of PSA \> 4,0 ng / mL; * Multiparametric prostate IRM, performed before inclusion and which confirm the diagnosis of suspected target; * No opposition of the patient notified in the medical record * patient member in a national insurance scheme. Exclusion Criteria: * Previous prostate biopsy; * suspicious digital rectal examination; * serum PSA \> 20,0 ng / mL; * treatment with 5 alpha reductase inhibitor during the last 3 months; * untreated urinary infection
References
Publications (1)
- RESULTDelongchamps NB, Portalez D, Bruguiere E, Rouviere O, Malavaud B, Mozer P, Fiard G, Cornud F; MURIELLE Study Group. Are Magnetic Resonance Imaging-Transrectal Ultrasound Guided Targeted Biopsies Noninferior to Transrectal Ultrasound Guided Systematic Biopsies for the Detection of Prostate Cancer? J Urol. 2016 Oct;196(4):1069-75. doi: 10.1016/j.juro.2016.04.003. Epub 2016 Apr 12. PMID 27079582