Ablatherm: An Ultrasound Device For Prostate Canc...( esults for 50 patients have just been p...),Health

esults for 50 patients have just been published. The trial, authorized by the Lyon Ethics Committee in 1992, involved patients over 67 (mean age 71 years) who had localized prostate cancer and did not qualify for radical prostatectomy (i.e. removal of the prostate). The results of the ultrasound treatment were assessed by monitoring changes in the PSA level in blood and biopsy specimens obtained at regular intervals. The patients underwent a thorough investigation within the year following treatment to check for metastatic spread to other parts of the body. The results were analyzed with a mean follow-up period of 340 days.

Local disease control in 80% of cases

• The treatment was considered a success in 28 of the 50 patients, i.e. those who had a complete response (the control biopsies showed no residual cancer cells, and the mean PSA level fell significantly then stabilized ).

• 12 patients had a partial response to treatment: residual cancer cells were detected in 9 patients although their mean PSA level had normalized, while the other 3 patients had no residual cancer cells but a slightly elevated PSA level.

• Finally, treatment was considered to have failed in the remaining 10 patients, 3 of whom required hormone therapy and 7 external radiation therapy.

These results show that treatment with the Ablatherm device can provide local disease control in approximately 80% of cases (complete control in 56% and partial control in 24%).

As regards adverse effects, 14 (31%) of the patients in this study had one or several complications, but an improved prototype has been found to give a far lower rate of complications (17%). The risk of incontinence is low (18%), and the impact on sexual function is not yet known.

It's too early to say how useful this device will be in the treatment of localized prostate cancer. Only 13 patients have more than three years' follow-up since treatment, and the promising initial results
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Contact: Jean-Yves Chapelon
chapelon@lyon151.inserm.fr
33-4-72-68-19-30
French National Institute for Health and Medical Research (INSERM)
22-Feb-1999

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