High-intensity focused ultrasound and XXXX : efficacy results from the European multicentric study.

@entity1 @entity263 @entity1486
PURPOSE: To describe the safety and efficacy of high-intensity focused ultrasound (HIFU) for the treatment of @entity263 as assessed in a Phase II/III prospective multicentric clinical trial. @entity1 AND METHODS: @entity1 (N = 402) presenting with localized (stage T(1-2)N(0-x)M(0)) @entity263 between 1995 and 1999 at six European sites who were not candidates for radical prostatectomy were treated with HIFU under general or spinal anesthesia. Their mean age was 69.3 +/- 7.1 (SD) years, the mean prostate volume 28.0 +/- 13.8 cc, and the mean serum @entity1486 (PSA) concentration 10.9 +/- 8.7 ng/mL. Nearly all (92.2%) of the @entity1 had one to four positive biopsy samples at baseline. The Gleason scores were 2 to 4 for 13.2% of the @entity1 , 5 to 7 for 77.5%, and 8 to 10 for 9.3%. During the follow-up, random sextant biopsies and serum PSA measurements were performed. Any positive sample in biopsies performed after the last treatment session resulted in a "HIFU failure" classification. RESULTS: The @entity1 received a mean of 1.4 HIFU sessions. The mean follow-up duration was 407 days (quartile 1 135 days, median 321 days, quartile 3 598 days). The negative biopsy rate observed in the T1-2 primary-care population was 87.2%. These results were also stratified according to the usual disease-related risk classification, and as much as a 92.1% negative biopsy rate was observed in low-risk @entity1 . Nadir PSA results correlated with prostate size and the clinical procedure. CONCLUSION: These short-term results obtained on a large cohort confirm that HIFU is an option to be considered for the primary treatment of @entity263 .
