High Resolution PET-MRI Before Prostate Cancer HIFU

This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI
versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.

Participants with clinically localized, unilateral high grade prostate cancer (Gleason score
7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having
unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic
biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU
would receive both a standard mpMRI and 18F-fluciclovine PET-hrMRI.

Participants would then undergo a mapping biopsy using a standard sextant template plus
MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.

Inclusion Criteria:

- Prostate biopsy consisting of ≥ 10 tissue cores sampled

- PSA
- cT1-cT2c

- Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to
one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic
biopsy cores positive and >/= 50% of core involvement in at least one core

- Patient considering focal HIFU therapy

Exclusion Criteria:

- Previous local therapy for prostate cancer

- Inability to receive PET tracer

- Inability to receive MRI

- Suggestion of extracapsular extension or seminal vesicle invasion on imaging

- Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)

- Any other condition which, in the investigator's option, may make the patient a poor
candidate for participation in a clinical trial.