Clinical trial · Interventional
Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device
Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device in Patients With an Elevated PSA and a Positive Multiparametric MRI
NCT02524860CI-TRIAL-00026486unknownN/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 purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.
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 |
|---|---|---|---|
| Focal-Fusion Bx | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-ultrasound fusion device
- description
- Using the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging
- interventionNames
- Device: Focal-Fusion Bx
Primary outcomes (1)
- measure
- Proportion of biopsy cores positive for clinically significant cancer.
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- Number of men diagnosed with clinically significant and clinically insignificant cancer.
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Adult male subjects up to 80 years of age * Candidates for fusion biopsy * Elevated PSA levels * MP-MRI with lesions having a Prostate Imaging Reporting and Data System (PI-RADS) score greater than or equal to 3 (determined by a trained radiologist) * Subject is willing and able to read, understand and sign the Informed Consent Form document Exclusion Criteria: * Previous treatment for prostate cancer * Any contraindication to a standard TRUS prostate biopsy procedure * Refusal to sign the Informed Consent document
References
Publications (0)
Data not yet available
No reference posted for this study.