Mearini Luigi, D'Urso Leonardo, Collura Devis, Zucchi Alessandro, Costantini Elisabetta, Formiconi Andrea, Bini Vittorio, Muto Giovanni, Porena Massimo
Department of Urology, University of Perugia, Ospedale Santa Maria della Misericordia, Perugia, Italy.
J Urol. 2009 Jan;181(1):105-11; discussion 111-2. doi: 10.1016/j.juro.2008.09.024.
High intensity focused ultrasound is a minimally invasive treatment option for prostate cancer. Data from the literature show promising early oncological outcomes and a favorable side effect profile. This study is a preliminary report of the Italian experience (Perugia and Turin) of patients treated with the Sonablate(R)500 high intensity focused ultrasound device.
Between 2004 and 2007, 163 consecutive men with T1-T3 N0M0 prostate cancer underwent high intensity focused ultrasound with the Sonablate 500. Followup included prostate specific antigen tests at 1 month and then every 3 months after treatment, and a random prostate biopsy at 6 months. Failure was defined according to prostate specific antigen nadir, positive findings on followup biopsy and biochemical failure according to Phoenix criteria.
Median patient age was 72 years old, median baseline prostate specific antigen was 7.3 ng/ml, and disease stage was T1 in 44.1%, T2 in 42.5% and T3a in 13.4% of patients. Median followup was 23.8 months. After high intensity focused ultrasound treatment prostate specific antigen decreased to a median nadir of 0.15 ng/ml. Median prostate specific antigen at 3 and 6 months was 0.30 and 0.54 ng/ml, respectively. At 6 months the negative biopsy rate was 66.1%. There was no biochemical evidence of disease in 71.9% overall. On multivariate analysis prostate specific antigen nadir became the only independent predictor of no biochemical evidence of disease and positive biopsy at a cutoff of 0.40 ng/ml.
A favorable outcome of high intensity focused ultrasound is associated with lower baseline prostate specific antigen, lower prostate specific antigen nadir, lower Gleason score and lower tumor stage. As with any novel technology long-term data will be required before this technique gains widespread clinical acceptance.
高强度聚焦超声是前列腺癌的一种微创治疗选择。文献数据显示其早期肿瘤学结果令人鼓舞，且副作用较小。本研究是关于使用Sonablate(R)500高强度聚焦超声设备治疗患者的意大利经验（佩鲁贾和都灵）的初步报告。
2004年至2007年期间，163例连续的T1 - T3 N0M0前列腺癌男性患者接受了使用Sonablate 500的高强度聚焦超声治疗。随访包括治疗后1个月时的前列腺特异性抗原检测，之后每3个月检测一次，以及在6个月时进行随机前列腺活检。失败的定义依据前列腺特异性抗原最低点、随访活检的阳性结果以及根据Phoenix标准判定的生化失败情况。
患者中位年龄为72岁，基线前列腺特异性抗原中位数为7.3 ng/ml，疾病分期为T1的患者占44.1%，T2的患者占42.5%，T3a的患者占13.4%。中位随访时间为23.8个月。高强度聚焦超声治疗后，前列腺特异性抗原降至中位数最低点0.15 ng/ml。3个月和6个月时前列腺特异性抗原中位数分别为0.30和0.54 ng/ml。6个月时阴性活检率为66.1%。总体上71.9%的患者无疾病的生化证据。多因素分析显示，前列腺特异性抗原最低点在截断值为0.40 ng/ml时成为无疾病生化证据和活检阳性的唯一独立预测因素。
高强度聚焦超声的良好结果与较低的基线前列腺特异性抗原、较低的前列腺特异性抗原最低点、较低的Gleason评分和较低的肿瘤分期相关。与任何新技术一样，在该技术获得广泛临床认可之前，还需要长期数据。
