Clinical trial · Interventional
MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer
MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer. A Phase III Study
NCT01566045CI-TRIAL-00051500withdrawnN/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 (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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Core Needle MRI/US image fusion guided needle biopsy | Procedure | — | UNRESOLVED |
| Core Needle TRUS Needle biopsy (Transrectal ultrasound) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Core Needle TRUS biopsy (Transrectal ultrasound)
- description
- Patient receiving core needle TRUS biopsy (Standard of care biopsy)
- interventionNames
- Procedure: Core Needle TRUS Needle biopsy (Transrectal ultrasound)
- type
- EXPERIMENTAL
- label
- Core Needle MRI/US fusion guided biopsy
- description
- Patients receiving Standard of Care core needle TRUS biopsy will then receive the MRI / Ultrasound fusion core needle guided biopsy
- interventionNames
- Procedure: Core Needle MRI/US image fusion guided needle biopsy
Primary outcomes (1)
- measure
- Number of prostate lesions
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients must have a pre-operative MRI performed in accordance with our NSHSLIJ/NIH MR prostate imaging guidelines. 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 and 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 conscious sedation (if procedure to be performed with conscious sedation, and without general anesthesia). 6. PSA \> 2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association 7. Pre-biopsy prostate MRI as described above, showing targetable lesions within 2 months of biopsy 8. Able to tolerate a TRUS 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. Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia. 4. Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI) 5. Patients with uncorrectable coagulopathies.
References
Publications (0)
Data not yet available
No reference posted for this study.