Clinical trial · Interventional
MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
NCT04599218CI-TRIAL-00073585unknownN/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)
This research study is designed to determine if targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy is better than the standard of care ultrasound guided biopsy alone in diagnosing subjects with clinically significant prostate cancer with MRI visible lesions. This study will consist of comparing the standard of care (ultrasound guided prostate biopsy) with the protocol biopsy which consists of an ultrasound guided prostate biopsy and a MRI/US fusion tracked prostate biopsy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Elevated Prostate Specific Antigen | — | UNRESOLVED | — |
| Family History of Prostate Cancer | — | UNRESOLVED | — |
| Positive Digital Rectal Exam | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR/TRUS Fusion Guided Prostate Biopsy | Device | — | UNRESOLVED |
| MR US Fusion Guided Prostate Biopsy | Other | — | UNRESOLVED |
| Prostate Biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Males with Prostate Cancer
- description
- Each participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.
- interventionNames
- Other: Prostate Biopsy
- Other: MR US Fusion Guided Prostate Biopsy
- Device: MR/TRUS Fusion Guided Prostate Biopsy
Primary outcomes (1)
- measure
- Incidence of Prostate Cancer
- timeFrame
- 1 Month
- description
- Incidence of diagnosing subjects with prostate cancer with MR visible lesions
Secondary outcomes (3)
- measure
- Incidence of adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent. 2. Age greater than 18 years. 3. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation. 4. The ability to understand willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained. 5. Ability to tolerate sedation and or general anesthesia if required. 6. PSA \>1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association. 7. Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy 8. Able to tolerate an ultrasound guided biopsy. Exclusion Criteria: 1. Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study 2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure 3. Patients with uncorrectable coagulopathies.
References
Publications (0)
Data not yet available
No reference posted for this study.