Clinical trial · Interventional
Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided Biopsy
Prospective Multicenter, Randomized Study Comparing the Diagnostic Efficacy of a Targeted MRI/Ultrasound Fusion-guided Prostate Biopsy Versus a Systematic Transrectal Ultrasound-guided Biopsy in Men With at Least on Negative Prostate Biopsy
- 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)
Patients will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings.
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 |
|---|---|---|---|
| MRI/ultrasound fusion-guided prostate biopsy | Device | — | UNRESOLVED |
| Systematic transrectal ultrasound-guided prostate biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Transrectal ultrasound-guided biopsy
- description
- Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume)
- interventionNames
- Device: Systematic transrectal ultrasound-guided prostate biopsy
- type
- EXPERIMENTAL
- label
- B: MRI/ultrasound fusion-guided biopsy
- description
- Patients of arm B receive a targeted MRI/ultrasound fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
- interventionNames
- Device: MRI/ultrasound fusion-guided prostate biopsy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least one negative transrectal ultrasound-guided prostate biopsy * PSA \> 3.0 ng/ml or PSA velocity \>0.75 ng/ml/p.a. Exclusion Criteria: * Known prostate cancer * PSA \>50 ng/ml * Previous MRI-targeted prostate biopsy
References
Publications (0)
Data not yet available