Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions

Inclusion Criteria:

   - Biopsy proven adenocarcinoma of the prostate

   - Intermediate risk, organ-confined prostate cancer (T1a up to T2b) and voluntarily
   chooses Exablate, who may currently be on watchful waiting or active surveillance and
   not in need of imminent radical therapy

   - Up to 2 MRI visible Gleason 7 confirmed on mapping prostate biopsy that Investigator
   deems treatable within a single treatment session; may have secondary Gleason 6 on
   ipsilateral or contralateral side confirmed with biopsy and/or MRI

   - PSA less than or equal to 20ng/mL

Exclusion Criteria:

   - Evidence of distant prostate cancer including lymph node involvement and/or metastasis
   of cancer

   - Subject undergoing androgen deprivation therapy, initiating any new medication that
   can affect PSA, or history of bilateral orchiectomy

   - Active bladder cancer, active UTI, or untreated prostatitis

   - Untreated urethral stricture/bladder neck contracture

   - Prostate-specific chemotherapy, brachytherapy, cryotherapy, photodynamic therapy,
   radical prostatectomy, or focal therapy (excluding FUS); or any prior radiation
   therapy to the pelvis for prostate cancer or any other malignancy

   - Subjects with pathology or implants that may adversely impact treatment due to
   acoustics, imaging, or safe probe insertion

   - Subject not able or willing to tolerate the required prolonged stationary supine
   position during treatment

   - Contraindications to MRI