Transcript High Intensity Focused Ultrasound

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
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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
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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
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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:
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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
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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?