These short-term results obtained on a large cohort confirm that HIFU is an option to be considered for the primary treatment of localized prostate cancer.

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To decrease side effects observed after high-intensity focused ultrasound (HIFU) treatment for localized prostate cancer and to re-establish normal micturition in a patient population that often presents with concomitant prostate enlargement, the impact of a combined transurethral resection of the prostate (TURP) and HIFU has been evaluated. TURP and HIFU treatments were performed under the same spinal anesthesia. For the HIFU treatments, the Ablatherm device (EDAP SA, Lyon, France) was used. Selection criteria for HIFU treatment were localized prostate cancer, no previous treatment for prostate cancer, and prostate-specific antigen (PSA) pound 15 ng/mL at diagnosis. All patients meeting these criteria were considered for treatment and analysis. PSA nadir and stability, histology, International Prostate Specific Score (IPSS) and IPSS-quality of life, and morbidity were assessed during follow-up; 271 patients were selected: 96 in the HIFU group and 175 in the TURP plus HIFU group. A statistically significant impact was observed on catheter time (40.0 days versus 7.0 in median), incontinence (15.4% versus 6.9%), urinary infection (47.9% versus 11.4%), and the evolution of the post-treatment IPSS (8.91 versus 3.37 in average) in favor of the TURP plus HIFU group. No significant changes were observed regarding efficacy during short-term follow-up when considering a 25% retreatment rate in the HIFU group versus a 4% retreatment rate in the TURP plus HIFU group. The combination of a TURP and HIFU treatment reduces the treatment-related morbidity significantly. The patient management after a combined TURP and HIFU treatment is comparable with the management after a single TURP.

OBJECTIVES To compare the specificity and sensitivity of different definitions of biochemical failure in patients treated with high‐intensity focused ultrasound (HIFU) for prostate cancer, to identify the most accurate predictor of clinical failure after HIFU. PATIENTS AND METHODS Consecutively treated patients who underwent HIFU between October 1997 and July 2006 at two centres (Lyon, France; and Regensburg, Germany) were prospectively maintained within a central database and retrospectively reviewed for this study. Clinical failure was defined as a positive prostate biopsy after treatment, radiographic evidence of lymphatic or bony metastatic disease, or salvage treatment for prostate cancer (surgery, radiation, hormonal therapy or second HIFU). The serum prostate‐specific antigen (PSA) values after HIFU were assessed as a biochemical surrogate of a therapeutic success or failure. PSA threshold values, ‘PSA nadir plus’, PSA velocity, PSA doubling time and the American Society or Therapeutic Radiotherapy and Oncology and Phoenix definition of biochemical failure were all considered. The sensitivity, specificity, positive predictive value and negative predictive value of each biochemical definition for predicting clinical failure were determined. RESULTS The data from 285 patients (stage ≤ T2, PSA <15 ng/mL, Gleason score ≤7) were analysed. The median (range) follow‐up was 4.7 (2–10.9) years. The median PSA nadir was 0.13 ng/mL, which occurred at a median of 12.9 weeks after HIFU, and the median PSA at the last follow‐up was 0.76 (1.6–2.7) ng/mL. Clinical failure occurred in 71 patients (25%); 24 due to a positive biopsy and 47 through the use of an additional therapy. Biochemical events that best predicted clinical failure were ‘PSA nadir plus’ values of 1.1–1.3 ng/mL, PSA velocities of <0.3 ng/mL/year and PSA doubling times of 1.25–1.75 years. CONCLUSION A new definition of biochemical failure that is specific to patients treated with HIFU therapy is established, i.e. the ‘Stuttgart definition’, the ‘PSA nadir plus 1.2 ng/mL’.

At the time of diagnosis, prostate cancer is organ confined in 70% of the cases. A quarter of these patients undergo local therapy (surgery/radiation); 75% risk disease progression by "watchful waiting" or systemic side effects through hormonal ablation. Local high-intensity focused ultrasound (HIFU), as minimal invasive tissue coagulation (85 degrees C), ablates prostatic tissue with high precision. Since April 1996, 184 patients have undergone 232 sessions of transrectal HIFU therapy (average 90 min) under spinal anesthesia at 2.25/3.0 MHz, 50 W, and a penetration depth of 25 mm. The follow-up serum prostate specific antigen (PSA) concentration, sextant biopsies, International Prostate Symptom Score (IPSS), quality of life measures (QoL), and complaint registration provide the foundation for this clinical evaluation. Follow-up sextant biopsies (an average of 1.9) showed 80% of the patients to be cancer free. In men with residual cancer, the tumor mass was reduced more than 90%. The PSA nadir in 97% was <4 ng/mL, including 61% with values <0.5 ng/mL. After primary HIFU, no severe side effects (fistula, second or third grade incontinence, rectal mucosal burns) occurred. All patients had a suprapubic tube (average 29 days), and 33% needed a transurethral debris resection averaging 7 g. They were discharged within 23 hours. According to the short-term follow-up transrectal HIFU enables minimal invasive local prostate tissue ablation with high rates of negative biopsies, low PSA nadir, and low complication rate.