From 1995 to 1999, 559 prostate cancer patients were included in a European multi-center study. Most of the patients (n=402) were T-1 or T-2 prostate cancer patients treated with Ablatherm® HIFU as first choice therapy. In this T-1/T-2 population, negative biopsies were observed in 87.2% of the patients.

Large Cohort: European Multicentric Study 1


One important finding from these biopsy results shows that 92.1% of the low-risk patients (cancer involving less than half a lobe, PSA <10ng/ml and Gleason score lower or equal to 6) had negative biopsies during their long-term follow-up (up to 51 months).

Long-term Results Have Been Published

A 5-year experience was reported on 146 consecutive T-1/T-2 prostate cancer patients, with a PSA level of 15 ng/ml or less. The patients were treated with Ablatherm® HIFU in the University of Regensburg, Germany, between October 1997 and November 2002.

The median PSA nadir achieved after 3 months was 0.07 ng/ml and the median PSA level after a follow-up of 22 months was 0.15 ng/ml. Also, 87% had constant PSA levels of less than 1ng/ml and 93.4% of all patients had negative control biopsies. No severe stress incontinence was observed. Erectile function was preserved in 47.3% of patients, and the International Prostate Symptom Score and Quality of Life Index did not change from before to after treatment. Studies from Lyon, France where patients were followed for more than 5 years after treatment with the Ablatherm® HIFU showed similar results.

Over 90% of patients undergoing Ablatherm® HIFU therapy will not require further treatment for their prostate cancer. In those developing a recurrence, they remain candidates for surgery, radiation or hormone therapy. Ablatherm® HIFU treatment has a similar success rate to radical prostatetomy but has the major advantage of using non-invasive technology.

If the PSA remains elevated after one treatment, however, or if a biopsy shows residual cancer of the prostate, re-treatment may be necessary. Sometimes tissue around the nerve coming into the prostate is spared on the side of the prostate gland if it has not been found by biopsy to have cancer. If a “nerve sparing” procedure is done the re-treatment rate is higher. One unique advantage of treatment with Ablatherm® HIFU is the fact that treatment is repeatable: if the nerve sparing procedure does not eliminate the cancer, the procedure can be repeated.

The results demonstrate the efficacy and low-associated morbidity of Ablatherm® HIFU. Ablatherm® HIFU seems to be a valid alternative treatment for patients who are not eligible for radical prostatectomy or who do not want to experience the potential side effects of the operation.

Failures of EBRT

Cryotherapy and Ablatherm® HIFU

In those patients developing a recurrence of their cancer after they have received external radiation, few treatment options have been available. Ablatherm® HIFU now offers a non-invasive treatment with superior results and reduces complication rates.

Salvage HIFU% Salvage Cryotherapy%
Incontinence 35 (1) 73 (3,4)
Type 3 7 (1) 21 (3)
Obstruction 17 (1) 67 (3,5)
Impotence Information not available 85 (4)
Fistula 0 (1)
since 2002
8.7 (6)
Moderate to severe
perineal pain
less than 1% (2) 28 (4)
Success 38 (1)
30 months actuarial disease free
rate combining histologic and
biochemical results
19 (7)
35 months actuarial biochemical
disease free rate

Safety Results

The complications observed with the patients throughout European hospitals using the Ablatherm® HIFU device are quite homogeneous. The following is a chart outlining the main side effects in relation with the treatment of prostate cancer with the Ablatherm® HIFU. It is important to note that the index measuring the quality of life of the patients remains unchanged before and after the treatment.

Death 0%
Digestive complications 0%
Mild to moderate urinary incontinence 5%
Total urinary incontinence < 1%
Urethral stenosis 8%
Sexual impotence with nerve-sparing procedure 20%
Sexual impotence without nerve-sparing procedure 66%

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