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

The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential
to be an effective non-invasive treatment for intermediate risk, organ-confined prostate
lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring
treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated
patients, as described above.

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