MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer

Summary

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.

Eligibility

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.

Conditions6

Locations3 sites

Browse More Trials