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

Objective of this pivotal trial is to assess safety and initial effectiveness of ExAblate
MRgFUS in the treatment of intermediate risk, localized (organ confined) prostate lesions.

ExAblate treatment will be implemented as a focal lesion-selective therapy, directed at
pre-defined volume(s)/sector(s) in the prostate, identified by mapping biopsy and
multi-parametric MRI, rather than a whole gland or hemi-ablation treatment.

Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS
focal treatment of intermediate risk organ confined prostate lesions. The risk of ExAblate
treatment-related incontinence and impotence will also be assessed in this study.

Effectiveness: determine the lesion control effect of ExAblate's MRgFUS focal treatment of
intermediate risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy
results).

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