HIFU Douglas Chinn MD Chinn & Chinn Urology Arcadia, CA

WHAT IS HIFU? High Intensity Focused Ultrasound: Sound waves are generated by an ultrasound transducer These low power waves are focused into a small area, generating very high power

HIFU Energy Delivery High Intensity Focused Ultrasound: Low Intensity at Transducer Face (20-40 Watts/cm2) Translates to Very High Site Intensity at the Focal Point (1600 - 2000 Watts/cm2)

HIFU Kills Tissue Thermal (80-100 oC) Cavitation Mechanical (Shearing forces)

HIFU As opposed to radiation, this ultrasound energy is non-ionizing This means that any tissue in the unfocused path of HIFU is NOT injured or damaged in any way

Procedure Overview: This is a very minimally invasive procedure It utilizes a transrectal approach for imaging and treating There are no incisions or stab wounds Procedure takes 2-4 hrs Spinal/Epidural Anesthesia

Sonablate 500

Ablatherm

Sonablate 500

Ablatherm

Sonablate vs Ablatherm

Prostate Gland is divided into 6 treatment zones Treatment Planning 1,2 3,4 5,6 1 2 5 6 4 3 As a second important factor, -----. There are 2 types of tissue ablation pattern are available on the Sonablate-200 system. In Upper treatment pattern, treatment zone is placed in the inside of the prostate capsule. But, you can see from the slide, some part of the peripheral site is not treated. This means that viable cancer tissue is untreated. On the other hand, Lower part of the ablation pattern, total prostate including the capsule was ablated. However, we had concerned a capsular perforation as a severe complication. Prostate Gland is divided into 6 treatment zones

HIFU Treatment Serial images are acquired Treatment zones are mapped out and logged into the computer Treatment is then begun Treatment can be interrupted and changed at any time Live imaging occurs before each HIFU spike

HIFU Treatment

Sonablate Therapy Mode HIFU computer control allows very precise tissue targeting, allowing us to fine tune therapy Prostate Edge (NVB) External Sphincter

Subtotal Ablation Indiana University Medical Center Canine Studies on Prostate Sub-Total Ablation Protocol No Damage to Rectal Wall or Prostate Capsule

Complications Transient Incontinence 15% at 90 days – 0% at 180 days Dysuria 10% at 30 days – 0% at 180 days UTI 6% at 90 days – 0% at 180 days Perineal Discomfort 5% after 30 days – 0% at 180 days Impotence 6% at 90 days (1 of 16) Complication rates from Indiana University Medical Center Phase I Localized Prostate Cancer Studies

Indications for HIFU Clinically localized prostate cancer Stage T1c-T3 Any Gleason Score Radiation Failure Radical Failure if a mass can be localized T3-T4 palliative or debulking

Contraindications Extensive prostatic calculi Large prostatic calculus Gland size > 40cc (will need downsizing) Rectal stenosis Metallic foreign bodies in rectal wall History of rectal fistula

HIFU Post-Operative Recovery Catheterization for 14-30 days Moderate to Severe Sloughing Mild pain in abdomen possible Up to 3-6 months before excellent urinary stream & force

Complications of Treating CaP: Radical prostatectomy Incontinence 8-25% ED 60-75% Bowel dysfunction 1-3% Urethral stricture and BNC 5-10% Blood transfusion <5%

Complications of Treating CaP: Radiation: (ERT or Brachytherapy) Incontinence 11-15% Previous TURP >50% ED 50-70% Bowel dysfunction 15-30% Seed migration 30% Irritative symptoms 30%

Complications of Treating CaP: Cryosurgery ED 98% Incontinence 3% Fistula 0%

Complications of Treating CaP: HIFU Incontinence 0% ED Sonablate 500 <7% Ablatherm-earliest series 30% Bowel dysfunction 0%

Five year outcome comparisons Biochemical Disease Free Survival RP CRYO Brachy 3DCRT XRT HIFU Low 76-98% 60-92% 78-89% 76-87% 81-86% 70-71% Moderate 60-76% 61-89% 66-82% 51-58% 26-60% BDFS definitions do vary but are comparable

Five year outcome comparisons Negative Biopsy Rates

Five year outcome comparisons Morbidity Imp. Incont. (any pad) Rectal injury Urge Bleeding Diarrhea Fistula RP 51-96% 7-52% 6-16% 1-3% 6-19% RT 50-61% 0-15% 19-17% 13-17% 12-42% Cryo 82-100% 1.3-5.4% <0.5% HIFU 28-100% 0-23% < 0.5–7.5%

Sonablate 500 Next generation technology High resolution treatment planning Real time treatment feedback Integrated rectal protection

Morbidity Comparison Impotence Incontinence Rectal fistula Ablatherm 45-100% 1-23% <0.7-5% Sonablate® 28-30% 0-2% <0.5-5%

HIFU Not FDA approved in the U.S. Approved in Europe, Asia, Latin America Not covered by insurance Phase I & II FDA safety and efficacy trials have already been done Phase III trials hope to begin this year Not all patients will fit into the study criteria

HIFU Sites: Cabo San Lucas Puerto Vallarta Santiago, Dominican Republic

HIFU: Cabo San Lucas HIFU cost: currently $20,000 Airline cost (Alaska): $350/person Hotel Cost (RIU Cabo Palace): $300/person/nite Food and drink included at hotel Transportation between hospital and hotel included Airport taxi: $60-70 each way/taxi

AmeriMed Hospital Cabo San Lucas www.amerimed-hospitals.com

AmeriMed Hospital Opened March 2001 Modern, comfortable, air conditioned in-patient rooms with satellite TV Fully equipped modern ICU Fully equipped modern operating room Large birthing area CT Scanner, X-Ray & Ultrasound Well equipped laboratory with immediate results Hemodialysis Arthroscopy and laparoscopy Well trained bilingual neurosurgeon Ambulance services Medical office complex next to the hospital with all major specialists and subspecialists

Why HIFU? Very minimally invasive procedure Outpatient procedure, can travel the following day Aside from wearing a catheter, can resume all activities immediately Can be repeated Very low incidence of incontinence Excellent chance to preserve potency in properly selected patients

Downsides to HIFU? Must wear a catheter (radical & cryosurgery) Will have variable urethral sloughing (cryosurgery & radiation) No 10 year data (5 year data is available) Not FDA approved Not covered by insurance Difficult/unable to treat seminal vesicle disease (seeds, surgery, cryo)

Current Applications of HiFu Prostate Cancer BPH Renal Tumors Liver Tumors

New Potential Applications of HiFu Pancreatic Cancer Breast Cancer Brain Cancer Cardiac Node Ablation