Clinical trial · Interventional
MR-targeted vs. Random TRUS-guided Prostate Biopsy
MR-targeted vs. Random TRUS-guided Prostate Biopsy in Patients With High PSA Values and Previous Negative Biopsy Results: A Randomized Controlled Trial
- 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)
To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least one previous negative prostate biopsy. Subjects will be submitted to a multiparametric MR scan of the prostate and subsequently patients with a suspicious MR for PCa presence will be randomized (1:1) into the two study arms.
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 |
| TRUS-guided prostate biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MR-targeted biopsy
- description
- Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MR imaging two targeted biopsy cores will be taken.
- interventionNames
- Device: MR-guided in-bore prostate biopsy
- type
- EXPERIMENTAL
- label
- TRUS-guided biopsy
- description
- Patients of arm B receive a saturation TRUS-guided prostate biopsy.
- interventionNames
- Device: TRUS-guided prostate biopsy
Primary outcomes (1)
- measure
- Prostate cancer detection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * men aged 50-80 * at least one negative TRUS-guided prostate biopsy * PSA \> 4 ng/ml * at least one suspected region detected at multiparametric MR imaging * signed informed consent Exclusion Criteria: * known prostate cancer diagnosis * contraindication against MR imaging or uncooperative patients
References
Publications (0)
Data not yet available