MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer

Inclusion Criteria:

• Men > 18 years of age;
• Histologically-proven prostate carcinoma;
• Prostate cancer clinical stage T1c
• Only one sector of the prostate demonstrating prostate cancer with no more than 1 core positive
• Gleason score <7 ;
• Each core must range between of 10 to 50% adenocarcinoma.
• Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
• A minimum of six (6) weeks between the prostate biopsy and the Inclusion Visit;
• Prostate specific antigen (PSA) level £ 10 ng/mL
• PORPUS, IPSS, and IIEF complete prior to procedure
• Prostate volume < 60 cc as measured by ultra sound;
• Uroflow >12 cc/sec with post void residual < 100 cc.
• Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer.

Exclusion Criteria:Patients with any of the following exclusion criteria will be excluded from study participation:

• Patients who are unwilling or unable to give informed consent;
• Patients with foci location in the Apex of the prostate or isolated transition zone cancers
• Patients who have received androgen suppression therapy
• Patients who have received or are receiving chemotherapy for prostate carcinoma;
• Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave, TURP ,cryotherapy or any curative treatment
• Patients whose has undergone radiation therapy for prostate cancer
• Any condition, or history of illness or surgery that, in the opinion of the Investigator , might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies);
• Patients with a history of non compliance with medical therapy and/or medical recommendations;
• Patients who are unwilling or unable to complete the patient self-assessment questionnaires;
• Myocardial infarction, transient ischemic attack or stroke, within 6 months prior to the study, Unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias
• Chronic or acute prostititis, neuroginic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
• Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days;
• All medications that cause a decrease clotting, vasoconstriction or platelet aggregation, must be stopped prior to treatment.
• History of Colon Cancer or Colon Surgery preformed
• If the patient is unable to undergo anesthesia
• Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent).
• Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study