Clinical trial · Interventional
Comparison of Prostate Fusion Biopsies With Software and Cognitive
Prospective and Randomized Study to Compare the Efficacy of Cognitive Fusion Prostate Biopsies and Prostate Biopsies Performed by "BK-fusion®" Software, for the Diagnosis of Significant 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)
This study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpMRI (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (BK-fusion®). Half of the patients included will undergo a systematic prostate biopsy + target biopsies by cognitive fusion and the other half of the population, will undergo a systematic prostate biopsy + target biopsies by software fusion.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fusion Prostate Biopsy | — | UNRESOLVED | — |
| Prostate Cancer Detection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive vs software | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 0: cognitive
- description
- target prostate biopsies by cognitive fusion
- interventionNames
- Diagnostic Test: cognitive vs software
- type
- EXPERIMENTAL
- label
- 1: software
- description
- target prostate biopsies by software
- interventionNames
- Diagnostic Test: cognitive vs software
Primary outcomes (1)
- measure
- Rate of overall prostate cancer and significant prostate cancer between the groups
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 40 years. * mpMRI carried out in our center. * Presence of lesions with PIRADSv.2 ≥ 3. * Acceptance to participate in the study. Exclusion Criteria: * PSA\> 30 ng / ml * Treatment with 5-ARIs (5-alpha-reductase inhibitors). * Previous diagnosis of PCa. * TR\> T3.
References
Publications (0)
Data not yet available