Clinical trial · Interventional
Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy
A Prospective Randomized Study Comparing the Diagnostic Efficacy of MR-guided in Bore Prostate Biopsy Versus MRI/US Fusion-guided Prostate Biopsy in Men With at Least One Negative Prostate Biopsy
NCT02220517CI-TRIAL-00017219completedN/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 hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more prostate cancers than targeted MR-guided in-bore 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 |
|---|---|---|---|
| MR-guided in-bore prostate biopsy | Device | — | UNRESOLVED |
| MRI/US fusion-guided prostate biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: MR-guided in-bore prostate biopsy
- description
- Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
- interventionNames
- Device: MR-guided in-bore prostate biopsy
- type
- EXPERIMENTAL
- label
- B: MRI/US fusion-guided prostate biopsy
- description
- Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)
- interventionNames
- Device: MRI/US fusion-guided prostate biopsy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least one prior negative prostate biopsy * Prostate-specific antigen (PSA) \> 4 ng/ml Exclusion Criteria: * Known prostate cancer * Contraindications against MRI * Contraindications against prostate biopsy
References
Publications (0)
Data not yet available
No reference posted for this study.