HIFU AND CRYOSURGERY David Spellberg M.D., FACS

HIFU with the Sonablate ® 500 The Sonablate ® 500 is a medical device that uses HIFU to thermally ablate the prostate.

What is HIFU? HIFU stands for High Intensity Focused Ultrasound Non-Invasive therapy that focuses sound waves to create heat Similar to light traveling through a magnifying glass to create heat Raises the temperature of the target tissue to almost 195 degrees Fahrenheit (90 degrees Celsius) Destroys the targeted tissues where sound waves cross 2000 W/cm 2 TransducerFocal Point

Status of HIFU in the US The Sonablate ® 500 is being studied in clinical trials for use in the treatment of prostate cancer in the United States and is not approved for use by the U.S. Food and Drug Administration. HIFU with the Sonablate ® 500 is authorized for use for the treatment of prostate cancer in Canada, Argentina and the Dominican Republic. It is also available in the Bahamas and Mexico.

Brief History of HIFU HIFU research began in the 1950s in Indianapolis, IN. Over the years HIFU has evolved to the applications we have today which include treating various types of cancer and diseases. In 2004, the first International HIFU Centers opened in the Americas.

The Sonablate ® HIFU Procedure 1-4 hour outpatient procedure, depending on size of prostate Spinal/epidural anesthesia with light sedative Therapy is delivered through a transrectal probe after patient is numbed from the waist down 1-2 hour recovery at HIFU treatment facility After procedure, most patients resume normal lifestyle within a few days In most cases, HIFU is a one time procedure. It is non-surgical, radiation free and has minimal blood loss.

Recovery & Follow Up Patients have a catheter that is removed days after HIFU. Office visit with doctor required for removal. Check PSA at 3, 6, 9 and 12 months then yearly thereafter.

Side Effects & Complications HIFU results from a study done in Japan show low rates of both –Impotence (<2%) –Incontinence (<0.6%) Minimal Complications –Discomfort associated with catheter –Tissue passing –Most are temporary and mild

MRI Pre and Post HIFU MRI Image of prostate Pre-HIFU MRI Image of prostate 2 weeks Post-HIFU

USHIFU Results & Data Physicians have treated more than 3000 patients in Mexico, the Dominican Republic and Canada. According to a Japanese study, the disease free rate after 6 years is 97% for low risk patients (PSA < 10; Gleason < 6) Another small study from the UK showed that 92% of men had Nadir PSA of 0.2 ng/ml or lower after 3 months.

Treats localized prostate cancer by freezing and destroying prostate cancer cells 13 A probe filled with liquid nitrogen is guided through a skin incision into the cancer tissue using transrectal ultrasound (TRUS), which allows the physician to monitor the freezing process 13 Cryosurgery 31

6/11/ Old Radiation Options: IMRT BRACHYTHERAPY HDR COMBINATION

6/11/ What is Radiosurgery? The use of precise, targeted delivery of high dose Radiation Radiation to deliver a surgical-like outcome Non-invasive alternative to surgery

6/11/ CyberKnife 2008

6/11/ Frameless referencing Near Real-time image guidance Robotics Advanced treatment planning What is the CyberKnife?

6/11/ Fiducials / Tissue Markers Fiducial for bone tracking Seeds for soft tissue tracking

6/11/ Summary Cyberknife is a new and innovative treatment technique for prostate cancer Cyberknife monotherapy appears to produce an earlier decline of PSA’s in low risk patients as opposed to other forms of radiation The acute toxicity of Cyberknife monotherapy is almost nonexistent Cyberknife therapy offers an exciting new, noninvasive and convenient treatment option for patients with prostate cancer

6/11/ Treats localized prostate cancer by freezing and destroying prostate cancer cells 13 A probe filled with liquid nitrogen is guided through a skin incision into the cancer tissue using transrectal ultrasound (TRUS), which allows the physician to monitor the freezing process 13 Cryosurgery 31

6/11/ What’s New in Urological Diagnosis and Treatment of Prostate Cancer David Spellberg M.D.,FACS

6/11/ You are not alone Prostate cancer is the second most common type of cancer diagnosed in American men 1,2  The projected risk of a 50-year-old man being diagnosed with prostate cancer during his lifetime is almost 10% 1  In 2008, an estimated 220,900 new cases of prostate cancer will be diagnosed in the US 2 3

6/11/ TargetScan® Trans-Rectal Ultra-Sound (TRUS) System

6/11/ Location & Record of Biopsy Sites Simultaneous transverse and sagittal images provide a record of biopsy locations. Additional (non- template) biopsies may easily be taken from other sites if warranted. TargetScan Screenshot

6/11/ TargetScan Biopsy Results Consistent across Centers/Urologists