Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

Inclusion Criteria

   - Biopsy proven adenocarcinoma of the prostate (using a IMAGE-guided 14+ core mapping
   biopsy), and targeted cores as needed obtained up to 6 months prior to scheduled
   treatment

   - Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to
   T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive
   treatment, who may currently be on watchful waiting or active surveillance and not in
   need of imminent radical therapy.

   - Patient with PSA less than or equal to 20 ng/mL

   - Gleason score 7 (4 + 3 or 3 + 4), based on mapping prostate biopsy, with no more than
   15mm cancer in maximal linear dimension in any single core

   - Single hemilateral index Gleason 7 lesion, identified in the prostate based on biopsy
   mapping with supporting MRI; may have secondary Gleason 6 lesion on ipsilateral or
   contralateral side confirmed with biopsy and/or MRI

Exclusion Criteria

   - Contraindications to MRI

   - History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy,
   Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any
   prior radiation therapy to the pelvis for prostate cancer or any other malignancy

   - Patient under medications that can affect PSA for the last 3 months prior to MRgFUS
   treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)

   - Individuals who are not able or willing to tolerate the required prolonged stationary
   supine position during treatment (approximately 3 hrs. sonication time)

   - Any rectal pathology, anomaly or previous treatment, which could change acoustic
   properties of rectal wall or prevent safe probe insertion (e.g., stenosis, fibrosis,
   inflammatory bowel disease, etc.)

   - Evidence of distant prostate cancer, i.e., including lymph nodes and/or metastasis of
   cancer on imaging

   - Bladder cancer

   - Urethral stricture/bladder neck contracture

   - Prostatitis NIH categories I, II and III

   - Implant near (<1 cm) the prostate