Objectives: To evaluate the efficacy of transrectal focused ultrasound on localized prostatic cancer.
Methods: Fourteen patients (mean age 72.5 years) with clinical stage T1 (3) and T2 (11) prostatic cancers, who were not suitable candidates for surgery were treated. The mean PSA pretreatment level was 12 +/- 10 ng/ml (Hybritech). The device used (Ablatherm, Technomed M.S.) combines a 2.25-MHz therapy transducer and a 7.5-MHz transrectal biplane ultrasound scanner probe (linked to a software enabling the operator to determine precisely the zone of the prostate to be treated. The prostate was treated in one (3 patients), two (7 patients) or three sessions (4 patients) under spinal (25 sessions) or general anesthesia (4 sessions).
Results: Complications occurred in 9 of the 14 patients (64%): early complications occurred in 6 (rectal burns 3, urinary retention 2, transient incontinence 1) and late complications in 5 (incontinence 2, bladder neck stenosis 3). The median PSA NADIR value (1.79 +/- 2.35 ng/ml) was achieved at 6 months and the final PSA value was 2.94 +/- 3.27 ng/ml (mean follow-up 380 days). Control biopsies demonstrated coagulative necrotic lesions of the treated prostate zones with secondary development into fibrosis. No residual cancer was observed in 7 patients after several random sextant biopsies. Residual cancer was found in 7 patients: 4 required complementary treatment (orchidectomy 2, external beam radiation therapy 2). Adjuvant therapy was deferred in 3 patients with stable PSA values under 2 ng/ml.
Conclusions: A satisfactory local control with negative control biopsies was achieved in 50% of the cases in this pilot study. However, this therapy is an investigational procedure: long-term follow-up will be necessary to confirm these early results.