Results

Seventy-one patients were treated in one HIFU session, 13 patients in two sessions, and 1 patient in three sessions, for a total of 100 procedures in 85 patients (1.2 sessions per patient). The reasons for repeat HIFU treatments were as follows: six patients were retreated because of short on (2sec) or long off (8 to 12 sec) intervals; four patients were retreated for residual tumor; two patients were hemilaterally treated on the right or left lobe of the prostate; two patients needed a repeat session to treat the whole prostate because of larger prostate size (37.9 and 50.6 ml); and one patient was retreated because of machine trouble. The median operating time and hospitalization was 150 min (range 30 to 356 min) and 4.0 days (range 3 to 20). A gradual reduction in prostate volume occurred in all patients. The gland size decreased from an initial volume of 25.6 mL (range 9.3-68.8 mL) to a final median volume of 12.5 mL (range 2.7 to 55.2) (p < 0.0001) in average 6.5 months (range, 3-23) interval.

Table 1 demonstrates the crude incidence of biochemical disease-free according to demographic and pretreatment characteristics. Totally, 73% (62/85 patients) showed a PSA disease-free-free survival (Fig. 5). Pretreatment PSA showed a statistically significant difference (p < 0.001) but clinical stage (p = 0.1233) and Gleason scores (p = 0.0759) were not significant difference. The 2-year biochemical disease-free survival rates for patients stage T1c, T2a and T2b were 76%, 72% and 42% (Fig. 6), respectively (p = 0.0831). The biochemical disease-free survival rate at 2 years for patients Gleason scores 2 to 4, 5 to 7 and 8 to10 were 94%, 65% and 57% (Fig. 7), respectively (p = 0.0538). In addition, the biochemical disease-free survival rates at 2 years for patients pretreatment

Table 1. Patient characteristics

Characteristics

All Pts

No. pts

85

Mean/median age (range)

70.3/70.0 (54-86)

Mean/median PSA (ng/ml)

10.90/16.07

Mean/median prostate volume (ml)

27.8/25.6

Pretreatment PSA (%):

10 or less

36 (42)

10.1-20

31 (36)

20.1-30

9 (11)

Greater than 30

9 (11)

Clinical stage (%):

T1c

49 (58)

T2a

27 (32)

T2b

9 (10)

Gleason score (%):

2-4

17 (20)

5-7

61 (72)

8-10

7 (8)

Fig. 5. Changes in serum PSA. Follow-up biopsies demonstrated intense coagulation necrosis at 2 months and extensive fibrotic tissue containing occasional atrophic glands without viable cancer cells at 6 and 10 months postoperatively. H, HIFU treatment
Pole Barn Electrical Wiring Diagram
Fig. 6. Clinical stage and biochemical disease-free curve by Kaplan-Meier method
Fig. 7. Gleason score and biochemical disease-free curve by Kaplan-Meier method

PSA less than 10,10.1 to 20,20.1 to 30 and more than 30ng/ml were 97%, 75%, 33% and 0% (Fig. 8), respectively (p < 0.0001).

In Cox regression analysis, preoperative PSA concentration (hazard ratio 1.059; p < 0.0001) and Gleason score (hazard ratio 1.440; p = 0.0466) demonstrated a statistically significant variables in these patients, but age, stages, prostatic volume, and neoadjuvant hormonal therapy were not statistically significant for prognosis (Table 2). Posttreatment prostate biopsies showed 91% (77/85) of the patients to be cancer free. The main pathological findings of prostate biopsy at 6 months after the procedure showed a coagulation necrosis and fibrosis.

Urinary symptoms such as frequency, urgency and difficulty urination were common during the first 2 months after HIFU treatment. The symptoms proved

Psa Biochemical Failure
Fig. 8. Pretreatment PSA and biochemical disease-free curve by Kaplan-Meier method
Table 2. Cox proportional hazards analysis of patients predicting time to biochemical failure following HIFU

Parameters

Hazard Ratio

95%CI

P Value

Age

1.036

0.966-1.111

0.3257

Stage

0.610

T1cN0M0

1.259

0.338-4.697

0.6827

T2aN0M0

0.722

0.152-3.437

0.9303

Gleason score

1.440

1.005-2.063

0.0466

Prostate volume

1.059

0.947-1.025

0.4659

Neoadjuvant therapy

0.680

0.224-2.057

0.4942

Preoperative PSA

1.059

1.036-1.082

<0.0001

to be transitory and were easily managed by medical treatment such as alpha-blockers or painkillers such as Voltaren suppository. Urethral catheter in all patients was removed 1 to 2 day postoperatively but catheter was re-indwelled in patients who could not urinate spontaneously and were tried to removal of catheter in every 1 to 2 weeks thereafter. The mean/median postoperative urinary catheterization time was 11/14 days (range 0-33 days). Final follow-up sextant biopsies showed 91% (77/85) of the patients to be cancer free. Fifteen (18%) patients developed a urethral stricture, 3 (4%) patients underwent transurethral resection of the prostate for prolonged urinary retention or ure-thral stricture, 2 (2%) and 1 (1%) patients developed epididymitis and a recto-urethral fistula. Twenty-eight % (18/25) patients complained postoperative erectile dysfunction. No incontinence was observed in follow-up.

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