Status:
UNKNOWN
MR/TRUS Fusion Guided Prostate Biopsy
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Philips Healthcare
Conditions:
Prostate Disease
Elevated Prostate Specific Antigen
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 c...
Detailed Description
The efficacy of targeting lesions for surgery may be limited by the visibility of a target during the procedure. The successful outcome of surgical intervention depends upon accurate device placement,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT04026763
Start Date
May 11 2018
End Date
December 1 2021
Last Update
July 19 2019
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 11101