HIFU History Technology ABLATHERM Treatment Positioning Benefits Device CLINICAL Effects Results Indications HIGHLIGHTS Ablatherm Ablatherm® The The HIFU Treatment for Localized Prostate Cancer HIFU TECHNOLOGY POWERED BY EDAP HIFU TECHNOLOGY POWERED BY EDAP
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HIFU ë History History Technology ABLATHERM Treatment Positioning Benefits Device CLINICAL Effects Results Indications HIGHLIGHTS Ablatherm Ablatherm ®
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HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
AblathermAblatherm®
TheThe HIFU Treatment
for Localized Prostate Cancer
HIFU TECHNOLOGY POWERED BY EDAPHIFU TECHNOLOGY POWERED BY EDAP
Typical PSA after AblathermTypical PSA after Ablatherm
Quality of life assessment (IPSS - QOL)*
Imaging Conclusion
PSA/PSA/Follow-upFollow-up
* Data collected in Munich (October 1, 2000)
• 52% of the patients with the same or an improved QOL
• Variation without clinical significance
• HIFU treatment does not adversely HIFU treatment does not adversely affectaffect
the patient’s QOLthe patient’s QOL Effects
3 / 3
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Clinical EffectsClinical EffectsImaging PSA/
Follow-upConclusiConclusionon
With Ablatherm®, the urologist:
obtains a complete necrosiscomplete necrosis of prostate tumors in the treated area without damaging the surrounding tissues, and without adversely affecting QOL
has an early assessmentearly assessment of the treatment efficacy (PSA nadir, histology…)
can repeatrepeat the treatment, since no maximum dose exists
Large cohort of patients: European Multicentric European Multicentric StudyStudy
Long term follow-up: Results from LyonResults from Lyon
Optimal Efficacy: Results from Munich Results from Munich
Minimal Morbidity: Results from Munich Results from Munich
Ref: C. Chaussy, S. Thüroff, G. Vallancien, W. Wieland, H.J. Kiel, A. Le Duc, F. Desgranchamps, J. de la Rosette, A. Gelet HIFU for the Treatment of Localized Prostate Cancer: Efficacy Results of the European Multicentric Study The Journal Of Urology, May 2001, Vol. 165, 5:388
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Patients included from 1995 to 1999, in 6 European sites:
A. Gelet, Lyon - FranceA. Gelet, Lyon - France
C. Chaussy, S. Thüroff, Münich - GermanyC. Chaussy, S. Thüroff, Münich - Germany W. Wieland, H.J. Kiel, Regensburg - GermanyW. Wieland, H.J. Kiel, Regensburg - Germany
G. Vallancien, Paris - FranceG. Vallancien, Paris - France
A. Le Duc, F. Desgranchamps, Paris - FranceA. Le Duc, F. Desgranchamps, Paris - France
J. de la Rosette, Nijmegen - The NetherlandsJ. de la Rosette, Nijmegen - The Netherlands
n = 559 patients
up to 51 months follow-upup to 51 months follow-up
Large Cohort: European Large Cohort: European Multicentric StudyMulticentric StudyEM StudyEM Study Long Term
Results
Conclusion
Adverse Events
Efficacy
1 / 5 The Journal Of Urology, May 2001
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
T1-T2 T3-T4
Orch./Hormonotherapy Prostatectomy
RX Failure
Mean age: 69 years (range 45 - 88)
n=402
n=35n=8n=104
n=10
EM StudyEM Study
Results
Long Term Conclusion
Adverse Events
Efficacy
STUDY POPULATIONSTUDY POPULATION
Large Cohort: European Large Cohort: European Multicentric StudyMulticentric Study
2 / 5 The Journal Of Urology, May 2001
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
T1-T2 PopulationT1-T2 Population Patients baseline Patients baseline
characteristicscharacteristics
< 10
10 - 20
> 20
Total
PSA (ng/ml)
50.9%
33.0%
16.1%
100%
2 - 4/G1
5 - 7/G2
8 - 10/G3
Total
Gleason score
10.5%
73.2%
16.3%
100%
0
1
2
3
4
5
6
Total
# Positivebiopsy
samples0.7% (TURP)
28.4%
29.5%
19.6%
6.5%
4.6%
10.7%
100%
EM StudyEM Study
Results
Long Term Conclusion
Adverse Events
Efficacy
Large Cohort: European Large Cohort: European Multicentric StudyMulticentric Study
3 / 5 The Journal Of Urology, May 2001
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Overall results observed in the T1 - T2 population
Negative biopsy Negative biopsy raterate
87.2%87.2%
Nadir PSA Nadir PSA ng/mlng/ml
25th 25th percentilepercentile
medianmedian
75th 75th percentilepercentile
afterafter complete treatmentcomplete treatment
0.00.0
0.10.10.40.4
after after
partial treatmentpartial treatment
0.10.1
0.60.6
2.22.2
EM StudyEM Study
Results
Long Term Conclusion
Adverse Events
Efficacy
Large Cohort: European Large Cohort: European Multicentric StudyMulticentric Study
4 / 5 The Journal Of Urology, May 2001
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Low-risk patients: T1-T2a and PSALow-risk patients: T1-T2a and PSA 10 ng/ml and Gleason score 10 ng/ml and Gleason score 6 6
Intermediate-risk patients: T2b or 10 < PSAIntermediate-risk patients: T2b or 10 < PSA 20 ng/ml or Gleason sc. = 7 20 ng/ml or Gleason sc. = 7
High-risk patients: T2c or PSA > 20 ng/ml or Gleason score High-risk patients: T2c or PSA > 20 ng/ml or Gleason score 8 8
Stratification of the results according to the initialdisease-related risk level
Large cohort of patients: European Multicentric European Multicentric StudyStudy
Long term follow-up: Results from LyonResults from Lyon
Optimal Efficacy: Results from Munich Results from Munich
Minimal Morbidity: Results from Munich Results from Munich
Ref: L. Poissonnier, A. Gelet et al. - Résultats du traitement par ultrasons focalisés transrectaux du cancer localisé de la prostate (120 Patients avec PSA à 10 ng/ml) - Progrès en Urologie, 2003, vol. 13, p. 60-72
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Long-term Follow-up: Results from Long-term Follow-up: Results from LyonLyon
Total population: n=120Total population: n=120
Clinical StageClinical Stage
Gleason ScoreGleason Score
Age (years)Age (years)
PSA Value (ng/ml)PSA Value (ng/ml)
Prostate Volume (cc)Prostate Volume (cc)
2 - 6:2 - 6: n = 77n = 777 - 10:7 - 10: n = n = 434371.2 71.2 5.3 5.3
5.67 5.67 2.47 2.47
33.6 33.6 15.5 15.5
Inclusion criteria:Inclusion criteria: Localized prostate cancer (T1-T2)Localized prostate cancer (T1-T2)HIFU: primary care for PCa treatmentHIFU: primary care for PCa treatmentInitial PSA Initial PSA 10 Ng/mL 10 Ng/mL
EM Study Long TermLong Term
Results
Conclusion
Adverse Events
Efficacy
1 / 3 Progrès en Urologie, 2001
T1: n = T1: n = 6161T2: n = T2: n = 5959
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Long TermLong Term
Results
EM Study Conclusion
Adverse Events
Efficacy
Long-term Follow-up: Results Long-term Follow-up: Results from Lyonfrom Lyon
Overall Disease Overall Disease Free Rate (DFR)Free Rate (DFR)FAILURE CRITERIONFAILURE CRITERION Positive random sextant Positive random sextant
biopsy biopsy (whatever the PSA level )
OROR (even if negative control biopsies)
– biochemical evidence ofbiochemical evidence of 3 3 consecutive rising in PSA consecutive rising in PSA levellevel
Large cohort of patients: European Multicentric European Multicentric StudyStudy
Long term follow-up: Results from LyonResults from Lyon
Optimal Efficacy: Results from Munich Results from Munich
Minimal Morbidity: Results from Munich Results from Munich
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Optimal Efficacy: Results from Optimal Efficacy: Results from MunichMunich
Results
Long TermEM Study Conclusion
Adverse Events
EfficacyEfficacy
• Patients evaluable for PSA nadir and/or stability: n Patients evaluable for PSA nadir and/or stability: n = 104= 104• Mean follow-up: 1 yearMean follow-up: 1 year
Inclusion criteria:Inclusion criteria: Localized prostate cancer (T1-T2)Localized prostate cancer (T1-T2)HIFU : primary care for PCa HIFU : primary care for PCa
Large cohort of patients : European Multicentric European Multicentric StudyStudy
Long term follow-up : Results from LyonResults from Lyon
Optimal Efficacy : Results from Munich Results from Munich
Minimal Morbidity : Results from Munich Results from MunichRef: C. Chaussy, S. Thüroff - High Intensity Focused Ultrasound: Complications and Adverse Events Molecular Urology, 2000, Vol. 4, 3:183-7