Clinical Results of HIFU

Clinical Studies

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).

1 High-Intensity Focused Ultrasound and Localized Prostate Cancer: Efficacy Results from the European Multicentric Study
S. Thuroff (1), C. Chaussy (1), G. Vallancien (2), W. Wieland (3), H.J. Kiel (1), A. LeDuc (4), F. Desgranchamps (4), J. de la Rosette (5), A. Gelet (6) Munich-Harlaching University, Munchen, Germany (1) - Institut Mutualiste Montsouris, Paris, France (2) - Caritas Krankenhaus, Regensburg, Germany (3) - Hopital Saint Louis, Paris, France (4) - University Medical Center St. Radboud, Nijmegen, The Netherlands (5) - Edouard Herriott Hospital, Lyon, France (6)

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.

(1) High-Intensity Focused Ultrasound for the Treatment of Localized Prostate Cancer:
5-year Experience . A. Blana, B. Walter, S. Rogenhofer, W.F. Wieland, University of Regensburg, Dept. Of Urology, Germany. Urology 63 (2), p. 297-300, 200

Last update: July 2004

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.

Ablatherm® HIFU has proven to be the most effective treatment for recurrent prostate cancer. Recently submitted but as yet unpublished results from France indicate that 100 consecutive unsuccessful EBRT patients show 62% of patients with negative biopsies and PSA's of <0.5 ng/ml at 3 months with no reported rectal fistulae (8). Complication rates are significantly lower with Ablatherm® HIFU than with salvage cryotherapy or salvage surgery.

(1) Local Recurrence of Prostate Cancer after External Beam Radiotherapy: Early Experience of Salvage Therapy using High-Intensity Focused Ultrasonography A. Gelet, J.Y. Chapelon, L. Poissonnier, R. Bouvier, O. Rouviere, L.Curiel, M. Janier, G. Vallancien (1), Edouard Herriott Hospital, Lyon - (1) Institut Montsouris, Dept. of Urology, France. Urology 63 (4), p. 625-629, April 2004

(2) High Intensity focused Ultrasound for the Treatment of Localized Prostate Cancer: 5-year Experience A. Blana, B. Walter, S. Rogenhofer, W.F. Wieland, University o Regensburg, Dept. of Urology, Germany. Urology 63 (2), p. 297-300, 2004

(3) Efficacy and Complications of Salvage Cryotherapy of the Prostate J. Urol., 157:921, 1997B Pisters, LL., vonEschenbach, A.C., Scott, S.M., Swanson, D.A., Dinney, C.P., et al

(4) Quality of Life After Salvage cryotherapy: Impact of Treatment Parameters J. Urol, 162:398, 1999 Perrrotte, P., Litwin, M.S., McGuirer, E.J., Shellie, M.S., van Eschenbach, A.C., et al

(5) Cryoablation of localized prostate cancer experience in 48 cases:PSA and biopsy results Eur Urol 34:181-187, 1998 Derakshani, P., Neubauer, S., Braun, M., et al

(6) Cryosurgery of prostate cancer: use of adjuvant hormonal therapy and temperature monitoring on one year follow-up. Anticancer Res. 17: 1511-1515, 1997 Lee F. Bahn DH, McHugh TA, et al:

(7) Percutaneous transperineal cryosurgery of the prostate as salvage therapy for radiation recurrence of adenocarcinoma. Cancer 77: 1510-1514, 1996. Miller RJ Jr, Cohen, JK, Shuman, B et al:

(8) HIFU Used as a salvage solution in local recurrences of Prostate Cancers after EBRT. Key factors contributing to treatment success
Pissonnier Laura*, Curiel Laura**, Bouvier Raymonde**, Husarik Daniela***, Rouviere, Olivier*, Chapelon Jean Yves** et Gelet Albert*
*Edouard Herriot Hospital, place D�Arsonval, 69437 Lyon, France
** INSERM unit 556, 151 cours Albert Thomas, Lyon, France
***Zurich University Hospital, Nuclear medicine services, Rami strasse 100, CH-8091 Zurich, Switzerland
Submitted for publication

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.

Gastrointestinal System

There have been no GI system complications reported when Ablatherm® HIFU was used in the initial treatment of T-1 or T-2 cancer of the prostate. In the cases where Ablatherm® HIFU was used in patients with previous radiation treatment failures, there were some reports of mild rectal burning.

Urinary System

Stenosis
Urethral Stenosis can occur in the months following the treatment due to scar tissue replacing the treated prostate tissue. In some cases a transurethral urethrotomy may be required.

Incontinence
In the first patients treated with Ablatherm® HIFU approximately 1 in 12 experienced either Type 1 or Type 2 incontinence which lasted an average one month. In recent months, further advancements in the Ablatherm® HIFU technologies have resulted in even fewer cases of initial Type 1 and Type 2 incontinence. Importantly, there are essentially no reports of patients with Type 3 incontinence unless patients have had previous radiation or surgery.

Sexual Function

Impotence
When the entire gland is treated, potency is retained in approximately 40% of cases. However, with a nerve sparing procedure, potency is retained in approximately 80% of patients. In addition, the majority of patients who are impotent following an Ablatherm® HIFU treatment will respond readily to oral medications (Viagra, Levitra, Cialis) for erectile dysfunction. Fortunately, many patients regain potency 6 to 12 months after treatment by the process of nerve regeneration.

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