Clinical trial · Interventional
MR/TRUS Fusion Guided Prostate Biopsy
MR/TRUS Fusion Guided Prostate Biopsy- An Improved Way To Detect And Quantify Prostate Cancer
NCT04026763CI-TRIAL-00039588unknownN/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 study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing subjects with prostate cancer.
Conditions
Conditions (4)
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 Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR/TRUS Fusion Guided Prostate Biopsy | Device | — | UNRESOLVED |
| MR US Fusion Guided Prostate Biopsy | Procedure | — | UNRESOLVED |
| prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Males with Prostate Cancer
- description
- Each participant will receive standard of care prostate biopsy as well as a US guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy guided prostate biopsy.
- interventionNames
- Procedure: prostate biopsy
- Procedure: MR US Fusion Guided Prostate Biopsy
- Device: MR/TRUS Fusion Guided Prostate Biopsy
Primary outcomes (1)
- measure
- Incidence of Prostate Cancer
- timeFrame
- Day 0 - day of procedure
- description
- Incidence of diagnosing subjects with prostate cancer with MR visible lesions
Secondary outcomes (3)
- measure
- Incidence of adverse events
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must have a pre-operative MRI performed in accordance with the MT Sinai/NIH MR prostate imaging guidelines. * Age greater than 18 years. * No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation. * The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained. * Ability to tolerate sedation and or general anesthesia if required. * PSA \>2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association * Pre-biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy * Able to tolerate a ultrasound guided biopsy Exclusion Criteria: * Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study. * Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure. * Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI) * Patients with uncorrectable coagulopathies.
References
Publications (1)
- DERIVEDWinoker JS, Wajswol E, Falagario U, Maritini A, Moshier E, Voutsinas N, Knauer CJ, Sfakianos JP, Lewis SC, Taouli BA, Rastinehad AR. Transperineal Versus Transrectal Targeted Biopsy With Use of Electromagnetically-tracked MR/US Fusion Guidance Platform for the Detection of Clinically Significant Prostate Cancer. Urology. 2020 Dec;146:278-286. doi: 10.1016/j.urology.2020.07.072. Epub 2020 Sep 18. PMID 32956688