A total of 100 HIFU procedures were performed over a 4-year period (between April 2006 and December 2011). Twenty-six patients who underwent first-line treatment were excluded because of followup <1 year as the procedure was performed in the last few months (n = 11), because they had their followup elsewhere (n = 9) or because they were not suitable for statistic evaluation, as they were not enough compliant to followup (n = 6). Three patients were lost to followup.
Of the remaining 74 patients, the age ranged from 65 to 80 with a mean of 72,7 years.
The proportion in the high-, intermediate-, and low-risk categories of D'Amico [6
] were 13,5%, 16,2%, and 70%, respectively, with a mean (SD) PSA level of 8,07 (±8,17)
ng/mL. Particularly, mean PSA level was 18,2 (±17,79)
ng/mL, 10,4 (±5,04) ng/mL, and 5,8 (±2,56)
ng/mL in the high-, intermediate-, and low-risk categories. Seventeen patients (28,3%) had received neoadjuvant therapy (ADT) for three months and this was discontinued immediately after HIFU.
Only seven patients underwent TUR-P at the same time of HIFU procedure.
Mean catheterization time was 9,3 days (±4,5). On the whole, 3 patients required interventions for either a stricture or endoscopic removal of necrotic tissue within the prostate cavity.
The overall mean PSA nadir was 1.12
ng/mL (±2,23), with a median of 0,95 and was obtained within a mean range of 3 ±2,3 months. A nadir value ≤0.2 was obtained in 31.6%. The nadir value was ≤1 in 76.6%.
Using the Phoenix criteria for biochemical failure, HIFU failed in 26.6% during a mean followup of 29.9 months (median 15 months, range 9–40 months).
Stratification of failure by D'Amico criteria [6
] was out of the 16 failures, 43.7% high-risk, 12.5% intermediate-risk, 43.7% low-risk. In the high risk group, failures were 87.5%, in the intermediate risk group 20% and in the low risk group 16.6%. Mean time to failure was 12.5 months, with a range of 3–40 months.
During the followup, 45 patients had prostate biopsies: 15.5% were positive. All these patients had biochemical failure.
At 3 months after HIFU, 13 patients complained of urinary incontinence (see ). In 6 of these patients urinary incontinence was transient and solved in 6 months. In the other 7 patients it was still present after twelve months (2
pads/die). They were investigated with urodynamic evaluation: 5 were treated with anticholinergic drugs; 2 were diagnosed with sphincteric incompetence and required artificial sphincter AMS-800.
The mean change in IPSS was 4.18 (±.4,16).
Sexual potency was defined according with the IIEF score system. 16 patients were potent before HIFU. Four men regained potency after HIFU. Four patients were partially impotent (a degree of erectile function was present but sexual intercourses were not possible) 6 months after HIFU. 5-phosphodiesterase treatment was proposed to these patients. IIEF score mean change was 11,6 (±3,6).
There was one rectovesical fistula. Diagnosis was provided by cystourethrogram and rectoscopy. This patient was managed with prolonged catheterization, as he declined any surgical procedure.
The procedure was well tolerated and no intraoperative or perioperative deaths occurred.