Clinical trial · Interventional
Transperineal, MRI-guided, Prostate Biopsy
Transperineal, MRI-guided, Prostate Biopsy: First Step to Focal Treatment of 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)
Primary purpose: Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are reduced than transrectal prostate biopsies. Secondary purposes: * Patients tolerance after transperineal prostate biopsy MRI-guided is better than after transrectal prostate biopsies. * Core of transperineal prostate biopsies are better than core of transrectal prostate biopsies * Study of correlation between radiologic images and anatomopathologic result * Description of needle track during the procedure * Description of real time template saturation prostate biopsy * Comparison of transperineal prostate biopsy relevance according to EBM * Comparison of 1.5T MRI and 3T MRI for prostate cancer detection
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 |
|---|---|---|---|
| Transperineal, MRI-guided, prostate biopsy | Procedure | — | UNRESOLVED |
| Transrectal prostate biopsy (TRB): | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transperineal prostate biopsy (TPB)
- description
- Transperineal prostate biopsy MRI-guided
- interventionNames
- Procedure: Transrectal prostate biopsy (TRB):
- type
- ACTIVE_COMPARATOR
- label
- Transrectal prostate biopsy (TRB)
- description
- Transrectal prostate biopsy echo-guided
- interventionNames
- Procedure: Transperineal, MRI-guided, prostate biopsy
Primary outcomes (1)
- measure
- Collection of complications and rehospitalizations by using questionnaire
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: * Men * 40 to 80 years' old * Affiliation to French social health system * Signed consent * Prostate cancer suspicion based on prostate specific antigen (PSA) or digital rectal exam WITH abnormal MRI (Prostate Imaging Reporting and Data System score 3) AND negative transrectal prostate biopsies * Patient treated by active surveillance for a low risk prostate cancer (T1c or T2a, Gleason = 6, PSA \< 10) Exclusion criteria: * Gleason \> 6 prostate cancer * Metastatic prostate cancer * Contraindication to MRI * Contraindication to general anesthesia * Non-reversible hemostasis trouble * Inability to give consent
References
Publications (1)
- RESULTTricard T, Cazzato RL, Poussot B, Gaillard V, Labani A, De Mathelin M, Barhoumi C, Sauleau E, Gangi A, Roy C, Lang H. Transperineal MR Imaging-Guided Prostate Biopsy: A Prospective Randomized Controlled Study on Safety and Effectiveness Compared with Transrectal Biopsy. J Vasc Interv Radiol. 2025 Aug;36(8):1278-1284. doi: 10.1016/j.jvir.2025.05.015. Epub 2025 May 17. PMID 40389061