HIFU Procedure

All patients were anesthetized by epidural or spinal anesthesia and were placed in the lithotomy position. A condom was placed over the probe, degassed water was used to inflate the condom, which was covered with ultrasound gel for close coupling of the ultrasound probe to the rectal wall, and the probe was inserted manually into the rectum. The probe was fixed in position by an articulating arm attached to the operating table. After selection of the treatment region of the prostate from the verumontanum to the bladder neck, the treatment was started. Transrectal probes with focal lengths of 2.5, 3.0, 3.5, 4.0, and 4.5 cm were used according to the size of the prostate, as determined by transrectal ultrasound (TRUS), with larger glands requiring longer focal lengths. The treatment continued layer by layer (10-mm thicknesses) from the apex to the base (Fig. 3). Usually, three successive target areas (anterior, mid-part, and base) were defined to treat the whole prostate (Fig. 4). After treatment had been completed, a transurethral balloon catheter, using a 14F or 16F Foley Balloon catheter, or percutaneous cystostomy was inserted into the bladder. Details of the HIFU techniques have been previously published [15,16].

Fig. 4. Whole prostate including prostatic capsule was treated with 6 parts divided to right and left sides of anterior, mid and base-part of the prostate

Fig. 4. Whole prostate including prostatic capsule was treated with 6 parts divided to right and left sides of anterior, mid and base-part of the prostate

Patient Recruitment

As a rule, the inclusion criteria for treatment were patients with stage T1c-2N0M0 localized prostate cancer and prostate volumes less than 50 ml. Patients with anal stricture were excluded from the study.All patients were fully informed of the details of this treatment and provided written consent preoperatively.

Between January 1999 and October 2002, 85 patients with clinically localized prostate cancer were treated with HIFU. Before undergoing HIFU, all patients underwent initial examination, including digital rectal examination. Pretreat-ment evaluation included history, physical examination (including digital rectal examination), initial PSA, and Gleason score on needle biopsy of the prostate. Serum PSA was determined by radioimmunoassay (Tandem-R method), with a normal range of 4.0ng/ml or less and a minimal detectable level of 0.008 ng/ml. All patients had a negative radionuclide bone scan and computerized tomography of the abdomen and pelvis confirming absence of metastatic disease. Tumors were staged using the TNM staging system [19]. The median patient age was 70 years (range, 54 to 86). The median PSA level was 10.90ng/ml (range, 3.39 to 89.60). The TNM stage was T1c in 49 patients (58%), T2a in 27 patients (31%), and T2b in 9 patients (11%). All patients had a histological diagnosis of prostatic adenocarcinoma according to the Gleason grading system. The histologic grade was Gleason score 3 to 4 in 17 patients, 5 to 7 in 61 patients, and 8 to 9 in 7 patients. Neoadjuvant hormonal therapy was delivered in 37 patients. The mean and median follow-up period for all patients was 20.6 and 20.0 months (range, 6 to 56), respectively.

Clinical Follow-up and Definition of Outcome

Patient status and treatment-related complications were followed up by all available means, including periodic patient visits and self-administrated questionnaires dealing with urinary continence and erectile function. Serum PSA was usually assayed every 1 to 6 months during follow-up. Postoperative prostate biopsy was performed in all patients at 6 months postoperatively. The American Society for Therapeutic Radiology and Oncology (ASTRO) Consensus Panel criterion for biochemical failure, i.e., three consecutive increases in posttreat-ment PSA after a nadir has been achieved, was used to define biochemical failure [20]. The time to biochemical failure was defined as midway between the post-

treatment PSA nadir and the first of three consecutive PSA increases. Prostate needle biopsies were performed in all patients at 6 months postoperatively. All patients had at least three PSA determinations during follow-up. None of the patients received androgen deprivation after HIFU or other anticancer therapy before documentation of a biochemical failure.

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