Clinical trial · Interventional
Comparison of MRI Fusion Biopsy Techniques in Men With Elevated PSA and Prior 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)
Men with elevated prostate specific antigen bloodtest and prior negative prostate biopsy have a 30-60% of harboring occult prostate cancer. Multiparametric magnetic resonance imaging (mpMRI) is an imaging test that may improve prostate cancer detection rates in this population of men. In this prospective randomized trial multicenter trial the investigators will assess the detection rates of prostate cancer diagnosis of systematic biopsy compared with the addition of either a computer targeted system (UroNav - InVivo corp) to sample suspicious areas identified on mpMRI versus the detection rate mpMRI guided freehand biopsy (cognitive fusion biopsy). The hypothesis being tested is that computerized fusion guided biopsy (UroNav) will increase detection prostate cancer compared to cognitive biopsy of these areas and systematic biopsy alone.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI UroNav fusion biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- MRI guided cognitive fusion biopsy
- description
- Men in this arm will undergo MRI followed by systematic biopsy and then additional cognitive (freehand) biopsies of MRI suspicious targets
- type
- EXPERIMENTAL
- label
- UroNav fusion biopsy
- description
- Men in this arm will undergo MRI followed by systematic biopsy and then additional UroNav fusion biopsy of MRI suspicious targets
- interventionNames
- Procedure: MRI UroNav fusion biopsy
Primary outcomes (1)
- measure
- Prostate cancer detection rate
- timeFrame
- 1 week after biopsy
- description
- Prostate cancer detection rate between MRI guided free hand biopsy and UroNav targeted biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * PSA \> 2.5 ng/ml (ages 30-50) or PSA \> 4.0 ages (50-79) * Patients with prior negative prostate biopsy * Written informed consent * Age \> 30 Exclusion Criteria: * Prior diagnosis of prostate cancer * Age\> 79 * No contraindication to MRI or prostate biopsy (e.g. coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies, anatomical contraindications) * Active urinary tract infection or indwelling catheter * Prior pelvic irradiation * Prior androgen deprivation hormonal therapy * Prostate surgery (e.g. prostate biopsy, transurethral prostate procedure) within 8 weeks prior to mpMRI. * Contraindication to MRI (extreme claustrophobia, metallic implants incompatible with MRI)
References
Publications (0)
Data not yet available