Murat F.J., Chapelon J.Y., Poissonnier L., Bouvier R., Rouviere O., Martin X., Gelet A.

Presented on March, 22 2007

INTRODUCTION & OBJECTIVES: To report our experience with the first generation HIFU device for the treatment of patients with localized prostate cancer.

MATERIAL & METHODS: Between 01/2000 and 04/2005, 463 patients, mean age 69.2 ± 19 years, with clinical (c) T1-T2 Nx M0 prostate cancer, not suitable for radical prostatectomy, with a PSA ≤ 15 ng/ml and a Gleason score (Gs) ≤ 7 were treated with the Ablatherm Maxis HIFU device. Mean PSA was 7.59 ± 3.25 ng/ml. cT1 and cT2 represented 246 and 217 patients, respectively. Gs was ≤ 6 and =7 in 299 and 164 patients, respectively. Mean prostatic volume was 23 ± 12ml. Follow-up included serial PSA measurements, control prostate biopsies at 3 months post-HIFU and in case of rising PSA. Biochemical failure was defined as PSA nadir + 2 ng/ml (ASTRO criteria 2005). Treatment failure was defined as PSA nadir + 2ng/ml or any positive prostate biopsy or salvage therapy introduction.

RESULTS: Mean follow-up was 23 ± 16 months. Control biopsies were negative in 84.5 % of the cases. The median PSA nadir achieved within 4 months was 0.10 ng/ml with a PSA nadir ≤ 0.5 ng/ml in 77% of the patients. The 4-year actuarial overall disease-free survival rate was 64%. This rate was inversely related to the clinical stage (cT1: 69% versus cT2: 57%, p<0.001) , the Gs (≤6: 72% versus =7: 48%, p<0.02) , the PSA (<4ng/ml: 84%, 4-10ng/ml: 61%, 10.1-15ng/ml: 39%, p<0.05) and the d’Amico initial risk level (low: 76% versus intermediate: 55%, p<0.0001). Urinary incontinence and bladder outlet obstruction accounted for 8% (grade 1: 6%, grade 2 :2%) and 8%, respectively.

CONCLUSIONS: HIFU is a minimally invasive therapy for patients with a localized prostate cancer not suitable for surgery. HIFU offers a local control in 84.5% of the cases and provides a disease control in 64% of the patients at 4 years.

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