Treatment began in 1997 and all were treated for curative intent with whole gland ablation. Patients in this report had at least 1-year follow-up. In addition to serial PSA measurements, patients underwent systematic control biopsy at 6 months with additional biopsies as indicated by a rising PSA. For those with recurrent CaP after the first HIFU treatment, patients were systematically offered a second session. A salvage therapy (external beam radiation therapy or hormonal deprivation) was given to those with a positive biopsy following the 2nd HIFU session. Kaplan-Meier analysis was performed to determine biochemical survival with failure defined according to the 2006 Phoenix definition (nadir +2).
A total of 880 patients were included in the analysis. Mean age was 70 years, mean PSA before treatment was 8.4ng/ml, 58% of the Gleason scores were <6, 34% were =7 and 8% ≥8. The clinical stage was T1 in 52% and T2 in 48%; stratification according to D’Amico’s risk group was low, intermediate and high in 36%, 48% and 16% respectively. Median follow-up was 41 months and mean number of treatment sessions per patient was 1.41. Mean PSA nadir was 0.45ng/ml with 69% reaching nadir ≤0.3ng/ml. Among the first control biopsies, 67% were negative for CaP. The overall and cancer specific survival rates at 7 years were 90% and 98%, respectively. The metastasis free survival rate at 7 years was 96%. The 5- and 7-year biochemical survival rates were 75%-62%, 59%-50% and 45-39% for low, intermediate and high risk patients, respectively (p=0.0001). PSA nadir was a major predictive factor for HIFU success with 5 and 7 years biochemical survival rates significantly influenced by the PSA nadir (≤0.3ng/ml: 75-67%, 0.31-1ng/ml: 42-31%, >1ng/ml: 18-8%; p<0.0001). Patients with biopsy proven local relapse underwent salvage external beam therapy or androgen deprivation in 156 and 83 patients, respectively.
Presented by Sebastian Crouzet, MD, et al. at the 26th Annual European Association of Urology (EAU) Congress - March 18 - 21, 2011 - Austria Centre Vienna, Vienna, Austria