RESUMEN
BACKGROUND: In patients with low-risk prostate cancer (PCa) the standard therapies carry a risk of overtreatment with potentially preventable side effects whereas restrained therapeutic strategies pose a risk of underestimation of the individual cancer risk. Alternative treatment options include thermal ablation strategies such as high-intensity focused ultrasound (HIFU). PATIENTS AND METHODS: 96 patients with low-risk PCa (D'Amico) were treated at 2 HIFU centres with different expertise (n=48, experienced centre Lyon/France; n=48 inexperienced centre Charité Berlin/Germany). Matched pairs were formed and analysed with regard to biochemical disease-free survival (BDFS) as well as postoperative functional parameters (micturition, erectile function). The matched pairs were discriminated as to whether they had received HIFU treatment alone or a combination of HIFU with transurethral resection of the prostate (TURP). Patients of the Lyon group were retrospectively matched through the @-registry database whereas patients of the Berlin group were prospectively evaluated. In the latter patients quality of life assessment was additionally inquired. RESULTS: Postoperative PSA-Nadir was lower in the Berlin group for patients with HIFU only (0.007 vs. Lyon 0.34 ng/ml; p=0.037) and HIFU+TURP (0.25 vs. Lyon 0.42 ng/ml; p=0.003). BDFS was comparable in both groups for HIFU only (Berlin 4.77, Lyon 5.23 years; p=0.741) but patients with combined HIFU+TURP in the Berlin group showed an unfavourable BDFS as compared to the Lyon group (Berlin 3.02, Lyon 4.59 years; p=0.05). In an analysis of Berlin subgroups especially patients who had received HIFU and TURP (n=4) within the same narcosis had an unfavourable BDFS (p=0.009). Median follow-up was 3.36 years for HIFU only and 2.26 years for HIFU+TURP. Neither HIFU only (p=0.117) nor HIFU+TURP (p=0.131) showed an impact on postoperative micturition. Erectile function was negatively influenced (HIFU: p=0.04; HIFU+TURP: p=0.036). There was no measurable change in quality of life after the treatment. CONCLUSION: The 4-year BDFS after HIFU and HIFU+TURP is comparable to that of the standard therapies. The erectile function is sustainably negatively influenced whereas postoperative micturition and quality of life were not affected by HIFU or HIFU+TURP. These results are strongly limited by the low patient count and the short follow-up period and require validation in prospective multicentre studies with higher number of cases.