Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study

Inclusion Criteria:

   1. Patient of age between 50 to 75 years, inclusive.

   2. Biopsy confirmed adenocarcinoma of the prostate, performed up to 6 months prior to
   scheduled treatment.

   3. Patient with low-intermediate risk, early-stage organ-confined prostate cancer (cT1c
   and cT2a, N0, M0), diagnosed with TRUS guided transperineal biopsy (TPBx) 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.

   4. Patient with PSA less than or equal to 10 ng/mL

   5. Gleason score 6 or 7 (no 5 grades), based on TRUS guided Transperineal Mapping Biopsy,
   as defined in the protocol.

   6. Up to two (2) cancerous lesions may be identified in the prostate; each tumor is not
   more than 10 mm in maximal linear dimension; each tumor should comply with the maximal
   7 Gleason score requirement.

   7. Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four
   (4) sectors, (2 for each cancerous focus) out of 16 sectors (or out of 12 sectors in
   prostates with volume <20 cc)

   8. Low grade tumors may or may not be visible by multi-parametric MRI. Thus, in case of
   MRI-visible tumor, tumor should be in capsular contact of less than 5 mm, on axial
   images.

   9. No definite evidence of extracapsular extension or seminal invasion by MRI

10. Patient eligible for epidural anesthesia, and general anesthesia (in case of
   complication, requiring intervention).

11. Patient is willing and able to give consent and attend all study visits as defined in
   the protocol

12. Prostate gland volume should be no greater than 70 cc, volumetrically measured.

Exclusion Criteria:

   1. ASA status > 2

   2. Contraindications to MRI 2.1. Claustrophobia 2.2. Implanted ferromagnetic materials or
   foreign objects 2.3. Known intolerance to the MRI contrast agent (e.g. Gadolinium or
   Magnevist) 2.4. Known contraindication to utilization of MRI contrast agent

   3. Severely abnormal coagulation (INR>1.5)

   4. Patient with unstable cardiac status including:

   4.1. Unstable angina pectoris on medication 4.2. Documented myocardial infarction
   within 40 days prior to enrolment 4.3. Congestive heart failure NYHA class IV 4.4.
   Unstable arrhythmia status, already on anti-arrhythmic drugs

   5. Severe hypertension (diastolic BP > 100 on medication)

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

   7. History of orchiectomy, PCa-specific chemotherapy, 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.

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

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

10. Any rectal pathology, anomaly or previous treatment, which can change acoustic
   properties of rectal wall or prevent safe probe insertion (e.g., fistula, stenosis,
   fibrosis).

11. Any spinal pathology which can prevent safe administration of epidural anesthesia

12. Identified calcification of 2 mm or more in largest diameter neighboring the rectal
   wall (in a distance of less than 5 mm) and interfering with the acoustic beam path.

13. Lower limb musculo-skeletal fixed deformities.

14. Prostate with multiple cystic lesions.

15. Evidence for seminal vesicle/lymph node involvement of cancer.

16. Subjects with distance of the less than 2mm margin between the tumor and the prostate
   capsule

17. Bladder cancer

18. Patient that had TURP procedure before

19. Urethral stricture/bladder neck contracture

20. Patient with baseline symptoms of incontinence defined as urine leak in any of the
   following circumstances:

   20.1. Before the patient can get to the toilet 20.2. When coughing or sneezing 20.3.
   While being asleep 20.4. While being physically active/exercising 20.5. After
   finishing urinating and being dressed 20.6. Leaking for no obvious reason

21. Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM) questionnaire

22. Active UTI

23. Prostatitis NIH categories I, II and III

24. Implant near (<1 cm) the prostate

25. Interest in future fertility

26. Current participation in another clinical investigation of a medical device or a drug
   or has participated in such a study within 30 days prior to study enrollment