2_Murat_HIFU_Uro.ppt

Ablatherm® efficiency on long-term results

Dr. F.J. Murat Lyon, France

Ablatherm® efficiency on long-term resultsHIFU device evolution

First prototype: 1993 -1995

Second prototype: 1995-2000

First generation ABLATHERM « maxis »:

2000-2005

Last generation « Integrated Imaging »:

2006-

1993 1995 2006Study period

Ablatherm® efficiency on long-term results

October 1997-August 2001

• 3 centers :

– Edouard Herriot Hospital, Lyon, France

– Krankenhaus, Munich, Germany

– St Josef Hospital , Regensburg, Germany

• Inclusion criteria :

– cT1-T2 Nx/0 M0

– PSA ≤ 15 ng/mL

– Gleason score ≤ 7

– No radical treatment for prostate cancer.

– Previous hormone-therapy ≤ 3 months

• 5-year minimum follow-up

• Prototypes and First generation HIFU devices

Ablatherm® efficiency on long-term results

• Follow-up:– PSA: 3 months and every 6 months

thereafter.

– Prostate biopsies: • 3 - 6 months after HIFU• in case of rising PSA (> 0.75 ng/ml/year).

• Patient record updates: May and August 2006.

Ablatherm® efficiency on long-term resultsStudy Population

• 140 patients

– Mean age: 69.1 ± 6.6 years – Mean PSA: 7.0 ± 3.5 ng/ml– Mean prostatic volume: 25.9 ± 11.2 cc

51,4% Low risk48,6% Intermediate risk

Ablatherm® efficiency on long-term resultsStudy Population

• HIFU devices

– Average HIFU sessions = 1.3– ≤ 3 months hormone-therapy:

• 16.4%

• stopped by the time of HIFU treatment• no statistical influence on oncological data

54,3% Prototypes45,7% First generation

Ablatherm® efficiency on long-term resultsGeneral Results

• Mean Follow-up:

6.4 ± 1.1 years

• PSA:– Mean PSA nadir: 0.62 ± 1.15 ng/ml.– Median PSA nadir: 0.16 ng/ml– Mean time to PSA nadir: 5 months

• Control Biopsy:

– Negative in 86.4 % – Low / intermediate risk patients: No difference (p = 0.31)

90% at 5 years83% at 8 years

(p = 0.23)

No death related to HIFU treatment

Ablatherm® efficiency on long-term resultsOverall survival*

* time of death, regardless of cause

Ablatherm® efficiency on long-term resultsProstate cancer-specific survival*

100% at 5 years98% at 8 years

* time of death from prostate cancer

86% at 5 years79% at 8 years

(p = 0.006)

Ablatherm® efficiency on long-term resultsSalvage treatment-free survival*

89%

69%

* time of a salvage treatment introduction

Ablatherm® efficiency on long-term resultsBiochemical failure-free survival*

73% at 5 years69% at 6 years

(p = 0.086)

*PSA < PSA nadir +2 ng/ml (ASTRO 2005)

Ablatherm® efficiency on long-term resultsDisease-free survival*

63% at 5 years59% at 6 years

(p = 0.012)

* PSA < PSA nadir + 2 ng/ml and negative biopsy and no hormone therapy (ASTRO 2005)

Ablatherm® efficiency on long-term resultsConclusions

• Local control achieved in 86.4%

• The following survival rates achieved at 5 years: – Overall 90%; – Prostate cancer-specific 100%;

– Salvage treatment-free 86%; – Biochemical failure-free 73%;– Disease-free 63%.

77%

Ablatherm® efficiency on long-term resultsBiochemical failure-free survival at 5 years

Katz AE and Rewcastle JC. Current Oncology Reports 5(3) pp. 231–238 (2003)

71%

Ablatherm® efficiency on long-term resultsBiochemical failure-free survival at 5 years

Katz AE and Rewcastle JC. Current Oncology Reports 5(3) pp. 231–238 (2003)

Ablatherm® efficiency on long-term resultsHIFU device evolution

First prototype: 1993 -1995

Second prototype: 1995-2000

First generation ABLATHERM « maxis »:

2000-2005

Last generation « Integrated Imaging »:

2006-

1993 1995 2006Study period

Ablatherm® efficiency on long-term resultsTake home message

• HIFU is a valid indication for localized prostate cancer in patients not suitable (age, co-morbidity) or refusing surgery.

• HIFU offers: – A high tumor local control

– A long-term efficacy comparable to other non-surgical options

A real ALTERNATIVE TO RADIATION or any other minimally invasive therapy

Prof. C. Chaussy and Dr. S. Thüroff,Krankenhaus, Munich, Germany

Prof. WF. Wieland and Dr. A. Blana,

St Josef Hospital, Regensburg, Germany

Dr. A. Gelet and Dr. L. Poissonnier,

Edouard Herriot Hospital, Lyon, France.

The authors thanks: