Inclusion Criteria:

- Patient age between 55 and 75 years, inclusive.

- Biopsy proven adenocarcinoma of the prostate (using a TRUS-guided 12+ core mapping
template), obtained up to 6 months prior to scheduled treatment.

- Patient with low-risk, early-stage organ-confined prostate cancer (cT1c and cT2a, N0,
M0) and voluntarily chooses MRgFUS 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 10 ng/mL

- PSAD <0.15 ng/mL/gr

- Gleason score 6 (3+3) or less (no 4 or 5 grades), based on TRUS-guided mapping
prostate biopsy, as defined in the protocol.

- Up to two (2) discrete cancerous lesions may be identified in the prostate based on
biopsy mapping with or without supporting MRI findings; each tumor is not more than
10 mm in maximal linear dimension; each tumor should comply with Gleason 6 = (3 + 3)
score requirements.

- No definite evidence of extracapsular extension or seminal invasion by MRI

- Patient should be eligible for both spinal/epidural anesthesia (planned procedure),
and general anesthesia (in case of complication, requiring intervention).

- Patient is willing and able to give consent attend all study visits and complete all
questionnaires as defined in the protocol

- Prostate gland volume should be no greater than 60 ml, volumetrically measured.

Exclusion Criteria:

- ASA status > 2

- Contraindications to MRI

- Claustrophobia

- Implanted ferromagnetic materials or foreign objects

- Known intolerance to the MRI contrast agent

- Severely abnormal coagulation (INR>1.5)

- Severe hypertension (diastolic BP > 100 on medication)

- Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

- 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 spinal pathology which can prevent safe administration of epidural/spinal
anesthesia

- Prostate with multiple cystic lesions.

- Evidence for lymph node involvement of cancer

- Bladder cancer

- Patients that had TURP procedure before

- Urethral stricture/bladder neck contracture

- Active UTI

- Prostatitis NIH categories I, II and III.

- Compromised renal function

- Implant near (<1 cm) the prostate