Transcript What is HIFU? - HIFU Romania

High Intensity Focused Ultrasound
Sonablate® HIFU
A Minimally Invasive Way to Treat Prostate Cancer
Updated 12/29/08
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 available for
use in Canada, the Dominican Republic, Argentina, the
Bahamas and Mexico.
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HIFU with the Sonablate® 500
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What is HIFU?
What is Sonablate® HIFU?
How does it work?
History of HIFU
Who Qualifies for HIFU?
The HIFU Procedure
Recovery & Follow Up
Does HIFU work?
Where is it available?
How can I get more
information?
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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
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HIFU with the Sonablate® 500
The Sonablate® 500 is a medical
device that uses HIFU to thermally
ablate the prostate.
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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.
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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.
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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.
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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
*Ahmed, HU, Salvage HIFU effectively reduces PSA in patients with biochemical recurrence after attempted curative treatment for prostate cancer. Poster
Presentation at the 29th SIU-Congress, Paris, September 2007.
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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.
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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.
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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
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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-
Incontinence:
approximately 2-4 weeks;
survival rate at 4 years
focused ultrasound waves to
0-2%
resume normal lifestyle almost
87% negative biopsy rate at 6
ablate 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
78% biochemical disease-free
using controlled freeze and
4-27%
possible overnight stay; return
survival at 1 year;
thaw cycles to destroy
Impotence:
to normal activities within a few
60% at 5-7 years;
cancerous cells
40-100%
days
88% negative biopsy rate at 5
years
Radical Prostatectomy
Major surgery to remove
Incontinence:
2-3 day hospital stay; catheter
85-91% biochemical disease-free
prostate; can be open
4-34%
for 2-3 weeks for open surgery;
survival at 2 years;
retropubic, laparoscopic or
Impotence:
shorter hospitalization and
68-72% biochemical disease-free
robotic
51-80%
fewer postoperative
survival at 10 years
complications for robotic
procedures
External Beam Radiation
6 to 8 week treatment,
Incontinence: 4-7%
Five treatments per week for 6
78% survival rate at 5 years
beaming radiation through
Impotence : 41-62%
to 8 weeks, up to 2 months
55-65% biochemical disease-free
healthy tissues
Bowel problems more
fatigue after full course of
survival rate at 5 years;
common than with other
treatment
49% at 10 years
treatments
Internal Radiation Seeds
(Brachytherapy)
Minimally invasive implants
Incontinence:
1-2 hour procedure with
85-91% biochemical disease-free
of radiation seeds in the
3-18%
possible overnight stay; return
survival at 10-12 years
prostate
Impotence:
to normal activities within a few
44-58%
days
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.
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*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
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Now that we know what
Sonablate® HIFU is…
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
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Where is HIFU Available now?
• International HIFU Centers
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Toronto, Ontario, Canada
Montréal, Québec, Canada
Bucharest, Romania
Cluj, Romania
Timisoara, Romania
Sofia, Bulgaria
Varna, Bulgaria
Puerto Vallarta, Mexico
Cancun, Mexico
Nassau, Bahamas
Information about individual centers is available
by request
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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
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General references
Thompson I, Thrasher JB, Aus G et al. Guideline for the Management of Clinically Localized Prostate Cancer: 2007 Update. J Urol 177:2106-2131, 2007
Prostate Cancer Treatment Guide™ http://www.prostate-cancer.com/
Prostate Cancer Treatments, Prostate Cancer Institute Online http://www.prostate-cancer-institute.org/prostate-cancertreatment/prostate-cancer-treatment.html
Sanda MG, Dunn RL, Michalski J et al. Quality of like and satisfaction with outcome among prostate-cancer survivors. NEJM 358:1250-1261, 2008
HIFU
Uchida T, Ohkusa H, Yamashita H et al. Five years experience of transrectal high-intensity focused ultrasound using the Sonablate device in the treatment of localized prostate
cancer. Intl J Urol 13:228-233, 2006
Uchida T, Ohkusa H, Nagata Y et al. Treatment of localized prostate cancer using high-intensity focused ultrasound. BJU Int 97:56-61, 2005
Cryosurgery
Cooperberg M, Carroll P, Shinohara K. Prostate Cancer: Cryotherapy. http://www.emedicine.com/med/TOPIC3539.HTM
Mouraviev V and Polascik TJ. Update on cryotherapy for prostate cancer in 2006. Current Opinion Urol 16:152-156, 2006
Bahn DK, Lee F, Badalament R et al. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology 60 (Suppl 2A):3-11, 2002
Han KR, Cohen JK, Miller RJ et al. Treatment of organ confined prostate cancer with third generation cryosurgery: preliminary multicenter experience. J Urol 170:1126-1130, 2003
Long JP, Bahn D, Lee F et al. Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology 57:518-523
Lam JS, Shvarts O and Belldegrun AS. Cryotherapy for PCa: the next generation. Contemporary Urol 16:2-12, 2004
Radical Prostatectomy
Han M, Partin AW, Zahurak M et al.: Biochemical (prostate specific antigen) recurrence probability following radical prostatectomy for clinically localized prostate cancer. J Urol 169:
517-523, 2003
Potosky AL, Davis WW, Hoffman RM et al.: Five-year outcomes after prostatectomy or radiotherapy for prostate cancer: the Prostate Cancer Outcomes Study. J Natl Cancer Inst
96(18):1358-1367, 2004
Roehl KA, Han M, Ramos CG et al.: Cancer progression and survival rates following anatomical radical retropubic prostatectomy in 3,478 consecutive patients: long-term results. J
Urol 172:910-914, 2004
Ung JO, Richie JP, Chen M-H et al.: Evolution of the presentation and pathologic and biochemical outcomes after radical prostatectomy for patients with clinically localized prostate
cancer diagnosed during the PSA era. Urology 60:458-463, 2002
External Beam Radiation Therapy
Madalinska JB, Essink-Bot M-L, de Koning HJ et al. Health-related Quality-of-Life effects of radical prostatectomy and primary radiotherapy for screen-detected or clinically
diagnosed localized prostate cancer. J Clin Oncol 19:1619-1628, 2001.
Potosky AL, Legler J, Albertsen PC et al. Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study. J Natl Cancer
Inst 92:1582-1592, 2000.
Rosser CJ, Chichakli R, Levy LB et al. Biochemical disease-free survival in men younger than 60 years with prostate cancer treated with external beam radiation. J Urol 168:536541, 2002.
Zietman AL, Chung CS, Cohen JJ et al. 10-Year outcome for men with localized prostate cancer treated with external radiation therapy: results of a cohort study. J Urol 171:210-214,
2004.
Brachytherapy
Grimm PD, Blasko JC, Sylvester JE et al. 10-Year biochemical (prostate-specific antigen) control of prostate cancer with 125I brachytherapy. Int J Radiation Oncology Biol Phys
51:31-40.
Potters L, Morgenstern C, Calugaru E et al. 12-Year outcomes following permanent prostate brachytherapy in patients with clinically localized prostate cancer. J Urol 173:1562-1566,
2005
Talcott JA, Clark JA, Stark PC et al. Long-term treatment related complications of brachytherapy for early prostate cancer: a survey of patients previously treated. J Urol 166:494499, 2001
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