MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
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. There are two biopsy approaches we are
 testing.

 Patients will have a choice to be enrolled into the transrectal (TRUS) or transperineal (TP)
 arms at their discretion.
The efficacy of targeting lesions for ultrasound-guided biopsy, surgery,or ablation may be
 limited by the visibility of a target during the procedure. The successful outcome of the
 intervention depends upon accurate device placement.

 Historically, prostate cancer was diagnosed by finger guided trans-rectal prostate biopsies.
 However, with the advent of PSA screening and improvements in ultrasonography, ultrasound
 guided prostate biopsy has become the standard of care to screen and diagnose men with
 prostate cancer. A standard 12-14 core prostate biopsy is now common practice, detecting
 cancer in 27% to 44% of patients in patients with an elevated serum PSA.

 Initially, prostate MR imaging was not considered for routine clinical practice. However, the
 addition of an endorectal-coil probe and a 3 Tesla magnet has improved its diagnostic
 utility. Currently, most mpMRI are done without the use of an endo-rectal coil at 3Tesla. The
 MRI is able to evaluate the entire prostate (transrectal ultrasound images are overlaid on a
 previously obtained prostate MRI, combined with an electromagnetic tracking system) prior to
 biopsy and allows the physician to target specific areas of the prostate that are suspicious
 for cancer. This contrasts with the typical US guided approach which samples regions of the
 prostate in a standard fashion.

 This study will consist of comparison of the standard of care prostate biopsy with the
 protocol biopsy which consists of a US guided prostate biopsy and a MR/US fusion tracked
 prostate biopsy in patients undergoing the transrectal (TR) or transperineal (TP) biopsy
 approaches. The researchers are interested in learning which procedure is more useful in
 obtaining a clearer picture of the prostate which will in turn provide a better way of
 finding abnormalities. Each patient will act as their own control.
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 pacemakers or automatic implantable cardiac defibrillators
 (contraindications to MRI)

 4. Patients with uncorrectable coagulopathies.