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Prostate Cancer High-intensity Focused Ultrasound
Figure 1: Published Data on High-intensity Focused Ultrasound –
and, based on these results, have presented standardised treatment
Negative Biopsies
strategies (see Figure 1).
100 The European multicentre study reports short-term results in 402
86
c
86
d 87
e
88
f
93
g
82
f patients with localised prostate cancer one year after HIFU treatment.
30
i
80
78
a
75
b 77
h
83
Control biopsies were negative in 87.2% of the patients, who were
stratified according to the prognostic risk. Of the patients with
60
negative control biopsies, 92.1% belonged to the low-risk group
n=402)
(Gleason score <7), 86.4% to the intermediate-risk group (Gleason
40
c
entre; score 7) and 82.1% to the high-risk group (Gleason score >7).
Negative biopsy rate (%) 8
2) 8
)
20
Prostate-specific antigen (PSA) nadir was usually achieved three to four
months post-treatment. PSA level was significantly influenced by
2000 (n= 2001 (n=102) 2003 (n=120) 2007 (n=227) 2003 (multi 2003 (n=96) 2003 (n=175) 2004 (n=146) 2006 (n=30) 2006 (n=5
0 prostate volume and the completeness of the treatment.
Gelet, Poissonnier Chaussy, Thüroff Blana Ficarra Lee
(Lyon) (Munich) (Regensburg) (Verona) (Seoul)
Ablatherm
In a clinical study in which HIFU treatment was performed one to two
weeks before radical prostatectomy, the effectiveness of HIFU was
a. Gelet et al., J Endourol, 2001;14(6):519–28; b. Gelet et al., Eur Urol, 2001;40(2):124–9;
c. Poissonnier et al., Prog Urol, 2003;13(1):60–72; d. Poissonnier et al., Eur Urol, 2007;51(2):
proved histologically. The complete histological work-up of the
381–7; e. Thüroff et al., J Endourol, 2003;17(8):673–7; f. Chaussy et al., Urol Rep, 2003;
prostate demonstrated the coagulative potency of HIFU. On
4(3):248–52; g. Urology, 2004;63(2):297–300; h. Ficarra et al., BJU Int, 2006;98(6):1193–8;
i. Prostate Cancer Prostatic Dis. 2006;9(4):439–43. histological examination of the specimens, a sharp demarcation was
seen between untreated and treated areas, with complete necrosis in
Figure 2: Published Data (T1–2, N0, M0) – No Evidence
of Disease
the treated regions.
32
The extent of the tissue damage caused by HIFU
was verified precisely by gadolinium-enhanced MRI. The treatment
100%
a
100
area appears as a non-enhanced hypodense zone surrounded by a
90%
b
84%
c
peripheral 3–8mm rim of enhancement. These abnormalities
80
78%
e
75%
d
74%
e 77%
f
77%
g
correspond to a central coagulative necrosis surrounded by a
60
peripheral zone of inflammation.
33
40
8
1)
Poissonier evaluated survival rates in a series of 120 patients with
Negative biopsy rate (%) 20
localised prostate cancer and PSA values <10ng/ml prior to HIFU
2002 (n=20) 2006 (n=30) 2004 (n=146) 2001 (n=72)
2006 (n=63) 2006 (n=1 2003 (n=120) 2007 (n=140)
treatment. None of the patients were suitable for radical prostatectomy
0
and all had an estimated life expectancy of 10 years.
34
Actuarial five-year
Year 1 Year 2 Year 3 Year 4 Year 5
disease-free rate was 76.9% for the overall patient population. This
Ablatherm Sonablate
significantly increased to 85.4% for patients with well-differentiated
a. Uchida et al., Urology, 2002;59(3):394–8; b. Ficarra et al., BJU Int, 2006;98(6);1193–8;
tumours (Gleason score 2–6) compared with 61.3% in patients with
c. Urology, 2004;63(2):297–300; d. Uchida et al., Hinyokika Kiyo, 2005;51(10):651–8;
poorly differentiated tumours (Gleason score 7–10). There was no
e. Uchida et al., Int J Urol, Hinyokika Kiyo, 2006;13(3):228–33; f. Poissonnier et al., Prog
Urol, 2003;13(1):60–72; g. Blana et al., Eur Urol, 2007.
significant difference in actuarial disease-free rates according to prostate
volume or number of positive initial biopsies. PSA nadir was regarded as
the AT2 and AT6 cancer sublines with high metastatic potential were a major prognostic factor with an actuarial five-year disease-free rate of
used.
19,20
The effect of HIFU on kidney tumours was also investigated 86% for patients with a PSA nadir <0.5ng/ml.
in experimental animal models.
21–25
These animal studies proved that
malignant cells can be destroyed without inducing metastasis.
20
The Blana et al. report on a study of 140 patients with localised prostate
transrectal use of HIFU for treatment of the prostate was studied in an cancer.
35
These patients had a PSA ≤15ng/ml and a Gleason score ≤7.
experimental dog model.
26,27
Six months after HIFU treatment, 93.4% of the patients had negative
control biopsies. Median PSA nadir was 0.07ng/ml and PSA level was
Clinical maintained at 0.16ng/ml over a mean follow-up of 22 months. After
With a total of 20,000 patients treated worldwide within the last 12 five years, the biochemical cure rate was 77%; after seven years it was
years, HIFU therapy for prostate cancer has found its place in clinical 69% (see Figure 2). They found no severe incontinence (grade II–III) in
routine.
5,28
Initial trials using HIFU for the treatment of benign prostatic this study population. Twelve per cent of the patients had to have a
hyperplasia (BPH) were not successful; therefore, this possibility is no transurethral resection of the prostate (TURP) because of obstructive
longer being pursued.
29
Two different technologies have been symptoms during follow-up. Potency could be maintained in 47.3% of
developed for the treatment of prostate cancer, both of which apply the patients. There were no significant changes in International
the energy via the transrectal approach. The first reports of Sonablate
®
Prostate Symptom Scores (IPSS) (see Figure 2). Five-year survival rates
(Focus Surgery, Inc., Indianapolis) were published in 2002,
4
while the corresponded to those seen in larger series of standard treatments for
results obtained with Ablatherm
®
(EDAP TMS SA, Vaulx-en-Velin) in a localised prostate cancer (see Figure 3).
European multicentre study in patients with localised prostate cancer
(T1–2, N0, M0) treated with HIFU from 1995 to 1999 were reported Side Effects
extensively in 2003.
30,31
In addition, all authors have reported The most commonly reported side effect of HIFU treatment is prolonged
separately about their experience with well-defined patient groups urinary retention caused by oedema, necrotic tissue debris or bladder
30 EUROPEAN UROLOGICAL REVIEW