Microsoft word - 12 clincal update uchida istu04.doc

CLINICAL OUTCOME OF HIGH-INTENSITY FOCUSED ULTRASOUND
(HIFU) FOR THE TREATMENT OF LOCALIZED PROSTATE CANCER:
5-YEARS EXPERIENCE
Toyoaki Uchida, Hiroshi Ohkusa, Hideyuki Yamashita, Yoshihiro Nagata Department of Urology, Tokai University Hachioji Hospital, 1838 Ishikawa-machi, Hachioji, Tokyo 192-0032, Objectives
Prostate cancer is the most common malignancy in men and second leading cause of
death due to cancer in the United States. Recently, a number of alternative less invasive
treatments have been developed to treat localized prostate cancer. High-intensity
focused ultrasound (HIFU) is a noninvasive treatment that induces complete coagulative
necrosis of a tumor at depth through the intact skin. We evaluated a biochemical disease-
free survival, predictors of clinical outcome and morbidity for localized prostate cancer
treated with HIFU.
Materials and Methods
A total of 152 HIFU treatments in 132 consecutive patients with stage T1c-2bN0M
localized prostate cancer have undergone using Sonablate® HIFU device (Focus Surgery,
Inc., Indianapolis, IN, USA). All patients followed more than 12 months. Disease freedom
was defined according to the criteria recommended by the American Society for
Therapeutic Radiology and Oncology consensus definition. The median age, serum PSA
and follow-up were 70 years (range 45-87), 10.5 ng/ml (range 3.39-89.6) and 17.0 months
(range 3 to 63). An average treatment time was 171 minutes (range 51-390). No adjuvant
therapy was given after HIFU therapy.
Results
The biochemical disease-free survival rates by Kaplan Meier curves at 1, 3 and 5 years
were in 83%, 69% and 69% of the patients. The biochemical disease-free survival rates
at 3 years for patients whose pretreatment PSA less than 10 ng/ml, 10.01 to 20.0, 20.01-
30.0 and more than 30 ng/ml were 88%, 67%, 61% & and 27% (logrank test, p<0.0001),
respectively. The biochemical disease-free survival rates at 3 years for patients with low,
intermediate and high risk group were 85%, 71% and 47% (p=0.0004), respectively. Final
follow-up prostate biopsies showed 85% (112/132) of the patients to be cancer free. On
multivariate analysis preoperative PSA (hazard ratio 1.061; 95%CI 1.040-1.083;
p<0.0001) was a significant independent predictor of clinical outcome but age, stage,
Gleason score, prostatic volume and neoadjuvant hormone therapy were not statistically
significant for prognosis. Thirty-three (25%) patients developed a urethral stricture, 7 (5%)
and 3 (2%) patients complained epididymitis and retrograde ejaculation. Four patients
underwent transurethral resection of the prostate for prolonged urinary retention due to
urethral stricture or bladder neck obstruction. One (1%) of each patient showed grade 1
incontinence for 1 month after HIFU and a rectourethral fistula. Twenty-two% (7/32)
patients complained postoperative erectile dysfunction. Two of 7 erectile dysfunction
patients were recovered with sildenafil citrate.

Conclusions
HIFU could noninvasively induce complete coagulative necrosis of the prostate without
requiring surgical exposure or insertion of instruments into the lesion. Moreover, HIFU
treatment is repeatable and, if needed, alternative options remain practicable. HIFU
therapy appears to be safe and efficacious minimally invasive therapy for localized
prostate cancer patients and pretreatment serum PSA was a useful predictor of clinical
outcome.

Source: http://www.euro-open.hu/doc/hifu/12_clinical_update_uchida_istu04.pdf