Clinical Data

To date, three institutions have reported on their experience with transrectal HIFU as a minimally invasive therapy for localized prostate cancer.6-8,24-29 Gelet et al. initiated a phase II

clinical trial in 1992 and reported in 1999 on 50 patients with localized prostate cancer unsuitable for radical prostatectomy who underwent a total of 113 HIFU treatment sessions.7 Median follow-up was 24 months (range 3-46 months). Negative post-HIFU biopsies and a prostate specific antigen (PSA) nadir of less than 4.0 ng/ml were seen in 28 patients (56%), 6% had negative biopsies but a serum PSA exceeding 4.0 ng/ml, yet 38% had residual cancer on the follow-up biopsies.7 The complication rate was as high as 50% with the first prototype; this number declined to 17% (urinary retention, urinary tract infection, bladder neck sclerosis, urinary incontinence) in those treated with a modified HIFU system.

The Munich group treated 184 patients with a total of 232 HIFU sessions; 80% were treated as a primary therapy for localized prostate cancer, 10% for local recurrences and 10% for local debulking.27-29 Mean operating time was 90 minutes. Follow-up biopsies were negative in 80%, and a PSA nadir of less than 4.0 ng/ml was observed in 97%, including 61% with a PSA nadir of <0.5 ng/ml (Table 56.1). All patients received a

Table 56.1. Outcome following HIFU treatment of localized prostate cancer (n = 184). Modified from Thuroff et al.29

PSA nadir following HIFU (ng/ml)

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