Safety Evaluation of ExAblate MRgFUS for Prostate Cancer

Inclusion Criteria:

• Age of patients: up to 75 years.
• Men scheduled for radical prostatectomy due to prostate cancer.
• Patients who are able and willing to give consent and able to attend all study visits.

Exclusion Criteria:

• Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
• Severely abnormal coagulation (INR>1.5)
• Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP > 100 on medication), and patients with cardiac pacemakers
• Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
• Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.)
• Any rectal pathology preventing probe insertion, (as active proctitis, ulcerative colitis, fissure ani, diverticulitis, previous rectal surgery, IBD, etc…)
• Any spinal pathology that prohibits maintaining supine position for more then an hour
• Any previous radiation to the pelvis.