MR/TRUS Fusion Guided Prostate Biopsy
Status unconfirmed · Not applicable
Conditions studied: Prostate Disease, Elevated Prostate Specific Antigen, Family History of Prostate Cancer, Positive Digital Rectal Exam
In brief
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.
Key facts
- Study ID
- NCT04026763
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 520
- Starts
- 2018-05-11
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2019-07-19
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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