Comparison of MRI Fusion Biopsy Techniques in Men With Elevated PSA and Prior Negative Prostate Biopsy

Prostate cancer (PC) is the second most common cancer in men in the United States, affecting
approximately 250,000 men per year. With the advent of the prostate specific antigen (PSA)
blood test, PC has undergone downward stage migration resulting in earlier cancer detection.
In the pre-PSA era, tumors presented with advanced stage which were often visible on
transrectal ultrasound. In the modern era, tumors more often are microscopic and not
apparent on ultrasound imaging which creates a diagnostic challenge in which biopsy is
essentially blind. As a result, many tumors are missed resulting in subsequent biopsies,
tumor progression, and decreased cancer-specific survival due to delayed diagnosis.

Multiparametric magnetic resonance imaging (mpMRI) of the prostate has now become the
preferred imaging modality to visualize prostate tumors radiographically. mpMRI has become
increasing utilized for targeting tumor suspicious areas in the prostate in men with prior
negative conventional systematic biopsy. Numerous studies have shown MRI targeted biopsy
results in detection of cancer in this subset of men in approximately 30-60% of patients
(refs). In addition, MRI detects a higher number of aggressive prostate cancers which would
require treatment.

Several methods of incorporating MRI into biopsy targeting have been tested: 1) in gantry/in
bore MRI biopsy 2) Robotic biopsy (Artemis) 3) UroNav ultrasound-MR fusion biopsy. The first
two techniques are cumbersome and difficult to use in clinical practice. The latter
technology is the most widely utilized, user and patient friendly technique. UroNav utilizes
a work-station which imports the MRI and then co-registers (fuses) it with real time
ultrasound; the ultrasound transducer communicates with an electromagnetic received above
the patient to allow the work-station/computer to target suspicious MRI lesions to guide the
users needle to the appropriate 3-dimensional location. Data has shown this to be more
effective than either systematic biopsy or free-MRI guided biopsy.

The goal of the present study is to compare head-to-head systematic biopsy + freehand MRI
targeted biopsy vs systematic biopsy + UroNav targeted in men with elevated PSA and prior
negative systematic biopsy.

Inclusion Criteria:

- PSA > 2.5 ng/ml (ages 30-50) or PSA > 4.0 ages (50-79)

- Patients with prior negative prostate biopsy

- Written informed consent

- Age > 30

Exclusion Criteria:

- Prior diagnosis of prostate cancer

- Age> 79

- No contraindication to MRI or prostate biopsy (e.g. coagulopathy, severe medical
comorbidity prohibiting halting of anticoagulation therapies, anatomical
contraindications)

- Active urinary tract infection or indwelling catheter

- Prior pelvic irradiation

- Prior androgen deprivation hormonal therapy

- Prostate surgery (e.g. prostate biopsy, transurethral prostate procedure) within 8
weeks prior to mpMRI.

- Contraindication to MRI (extreme claustrophobia, metallic implants incompatible with
MRI)