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High Intensity Focused Ultrasound Sonablate® HIFU A Minimally Invasive Way to Treat Prostate Cancer David Spellberg, MD Naples Urological Associates Prostate Cancer Statistics Prostate Cancer is the most common cancer among men and is the 2nd leading cause of cancer deaths. 1:6 men will get Prostate Cancer. African American men are more likely to get Prostate Cancer. If you have a family history of Prostate Cancer, your risk of getting Prostate Cancer doubles. Approximately 220,000 men will be diagnosed with Prostate Cancer this year. That means that 1,048 men per work/clinic day will be diagnosed with the disease. Every minute of each work day, 2.18 men are told they have Prostate Cancer. That is one man every 28 seconds! Approximately 30,000 men will die from prostate cancer each year. 1:8 men with Prostate Cancer will die from it. Each day, 82 men will die from Prostate Cancer. Every hour, 3.42 men die form Prostate Cancer. A Prostate Cancer death occurs every 17:31. Incidence increases with age: Between the ages of 40-59, 1 in 55 men will develop prostate cancer Between the ages of 60-79, 1 in 7 men will develop clinically significant disease. Prostate Cancer can be treated. Prostate Cancer can be cured. Men diagnosed with Prostate Cancer can live a normal life time. Most men with Prostate Cancer die from heart related diseases Prostate Cancer Screening • • • • Prostate Exam Prostate Specific Antigen (PSA) Digital Rectal Examination (DRE) Transrectal Ultrasound Prostate Needle Biopsy (TRUS PNBx) • Bone Scan • CT Scan • MRI/ Prostascint, etc Treatment Options • • • • • • • • Radical prostatectomy (open or robotic) External beam radiation (IMRT) Seeds implantation (brachytherapy) Combination beam and seed implant Cryotherapy (total or focal) Hormone therapy Chemotherapy HIFU COMPLICATIONS OF TREATMENT • • • • • INCONTINENCE IMPOTENCE EJACULATION DYSFUNCTION BOWEL PROBLEMS WORSENING OF OVERALL HEALTH Localized Prostate Cancer • Effective treatment • Safe treatment • Minimal lifestyle changes Cost of Treatment • Open Radical Prostatectomy: $26,000-$47,000 • Robotic Radical Prostatectomy: $35,000-$104,000 • External Beam Radiation: $80,000-$150,000 • Interstitial Radiation: $60,000-$80,000 • Cryotherapy: $24,000-$36,000 • HIFU: $25,000 **Ranges shown above account for both regional differences and differences in patient outcomes and technologies but do not account for complications resulting from these treatments, which are an additional 50-75% of the original treatment 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/cm2 Transducer Focal Point HIFU with the Sonablate® 500 The Sonablate® 500 is a medical device that uses HIFU to thermally ablate the prostate. 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, outside of the United States. Who Qualifies for HIFU? Ideal HIFU candidate: • Localized prostate cancer • PSA < 10 • Gleason < 7 • Prostate Volume 40 cc • Other patients may also qualify and should discuss their specific case with a physician. Who else Qualifies for HIFU? HIFU can also treat recurrent prostate cancer. This includes: • • • • • Radiation failures Cryotherapy failures Prostatectomy failures Brachytherapy failures (seeds) HIFU failures ® Sonablate HIFU Today • Over 100 HIFU Centers, outside of the U.S., in North & South America, Europe, Asia, and other countries where the device is approved. • Over 7,000 patients treated with prostate disease (BPH and Cancer), outside the U.S. • Over 250 trained Sonablate® users worldwide. The Sonablate® HIFU Procedure • 1-4 hour outpatient procedure, depending on size of prostate • 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 2-4 weeks after HIFU. Office visit with doctor required for removal. • Check PSA at 3, 6, 9 and 12 months then yearly thereafter. Side Effects & Complications • All treatments for prostate cancer carry some risk for potential side effects and complications. • Side effects include frequency, urgency, mild discomfort or discharge in urinary stream. • Studies performed outside the US report that less common side effects (these may be more severe) may also include urinary stricture, retention, incontinence, impotence and rectal fistula. • As with any medical procedure, all potential side effects and complications should be discussed with a physician before undergoing therapy. • For a complete list of all possible risks associated with HIFU please refer to www.InternationalHIFU.com Results & Data Treatment Description Selected Risks Recovery Selected Outcomes High Intensity Focused Minimally invasive use of In approved countries Temporary catheter worn for 94% biochemical disease-free intersecting, precision-focused Incontinence: approximately 2-4 weeks; resume survival rate at 4 years ultrasound waves to ablate 0-2% normal lifestyle almost 87% negative biopsy rate at 6 diseased tissue Impotence: immediately months Ultrasound (HIFU) as approved and used outside the US Cryotherapy 20-30% Minimally invasive procedure Incontinence: 2-3 hour procedure with possible 78% biochemical disease-free using controlled freeze and thaw 4-27% overnight stay; return to normal survival at 1 year; cycles to destroy cancerous cells Impotence: activities within a few days 60% at 5-7 years; 40-100% Radical Prostatectomy 88% negative biopsy rate at 5 years Major surgery to remove Incontinence: 1-3 day hospital stay; catheter for 85-91% biochemical disease-free prostate; can be open retropubic, 4-34% 2-3 weeks for open surgery; survival at 2 years; laparoscopic or robotic Impotence: shorter hospitalization and fewer 68-72% biochemical disease-free 51-80% postoperative complications for survival at 10 years robotic procedures External Beam Radiation 6 to 8 week treatment, beaming Incontinence: 4-7% Five treatments per week for 6 to 8 78% survival rate at 5 years radiation through healthy tissues Impotence : 41-62% weeks, up to 2 months fatigue after 55-65% biochemical disease-free Bowel problems more full course of treatment survival rate at 5 years; common than with other 49% at 10 years treatments Internal Radiation Seeds (Brachytherapy) Minimally invasive implants of Incontinence: 1-2 hour procedure with possible 85-91% biochemical disease-free radiation seeds in the prostate 3-18% overnight stay; return to normal survival at 10-12 years Impotence: activities within a few days 44-58% Data presented are for clinically localized, low-risk primary prostate cancer, generally defined as PSA ≤10ng.mL, Gleason score ≤6, clinical stage T1 or T2a. Chart was researched and compiled by Synteract, a third party CRO. The information provided in the chart may not included all potential risk, recovery and outcome information. *For a complete list of general reference for all treatment modalities see end of presentation. MRI Pre and Post HIFU MRI Image of prostate Pre-HIFU MRI Image of prostate 2 weeks Post-HIFU If you are interested in HIFU, you will need to know the following: • PSA • Gleason • Prostate Volume (very important) • Other therapies/treatments and any relevant medical history Where is HIFU Available now? • International HIFU Centers • • • • • • • • Toronto, Ontario, Canada Brampton, Ontario, Canada Niagara Falls, Ontario, Canada Winnipeg, Manitoba, Canada Montréal, Québec, Canada Puerto Vallarta, Mexico Cancun, Mexico Nassau, Bahamas Status of HIFU in the US HIFU with Sonablate® 500 is not approved for use in the U.S. The Sonablate® 500 remains investigational in the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. The FDA has made no decision as to the safety or efficacy of the Sonablate® 500 for the treatment of prostate cancer. Currently the device is approved for use in Canada and the Dominican Republic, authorized in Argentina, and available in the Bahamas and Mexico. Where can I get more information? • Online: www.InternationalHIFU.com – Read patient comments, watch videos and more • Call to speak with a HIFU representative: 1-888-874-4384 • Patient Information Booklet and DVD • Speak with men who have already had HIFU -Thank YouQuestions?