Division of Surgery and Interventional Sciences, University College London, London, UK; Department of Urology, UCLH NHS Foundation Trust, London, UK.
Department of Radiotherapy, University Medical Centre, Utrecht, The Netherlands.
Eur Urol. 2018 Oct;74(4):422-429. doi: 10.1016/j.eururo.2018.06.006. Epub 2018 Jun 28.
Clinically significant nonmetastatic prostate cancer (PCa) is currently treated using whole-gland therapy. This approach is effective but can have urinary, sexual, and rectal side effects.
To report on 5-yr PCa control following focal high-intensity focused ultrasound (HIFU) therapy to treat individual areas of cancer within the prostate.
DESIGN, SETTING, AND PARTICIPANTS: This was a prospective study of 625 consecutive patients with nonmetastatic clinically significant PCa undergoing focal HIFU therapy (Sonablate) in secondary care centres between January 1, 2006 and December 31, 2015. A minimum of 6-mo follow-up was available for599 patients. Intermediate- or high-risk PCa was found in 505 patients (84%).
Disease was localised using multiparametric magnetic resonance imaging (mpMRI) combined with targeted and systematic biopsies, or transperineal mapping biopsies. Areas of significant disease were treated. Follow-up included prostate-specific antigen (PSA) measurement, mpMRI, and biopsies.
The primary endpoint, failure-free survival (FFS), was defined as freedom from radical or systemic therapy, metastases, and cancer-specific mortality.
The median follow-up was 56 mo (interquartile range [IQR] 35-70). The median age was 65 yr (IQR 61-71) and median preoperative PSA was 7.2 ng/ml (IQR 5.2-10.0). FFS was 99% (95% confidence interval [CI] 98-100%) at 1 yr, 92% (95% CI 90-95%) at 3 yr, and 88% (95% 85-91%) at 5 yr. For the whole patient cohort, metastasis-free, cancer-specific, and overall survival at 5 yr was 98% (95% CI 97-99%), 100%, and 99% (95% CI 97-100%), respectively. Among patients who returned validated questionnaires, 241/247 (98%) achieved complete pad-free urinary continence and none required more than 1 pad/d. Limitations include the lack of long-term follow-up.
Focal therapy for select patients with clinically significant nonmetastatic prostate cancer is effective in the medium term and has a low probability of side effects.
In this multicentre study of 625 patients undergoing focal therapy using high-intensity focused ultrasound (HIFU), failure-free survival, metastasis-free survival, cancer-specific survival, and overall survival were 88%, 98%, 100%, and 99%, respectively. Urinary incontinence (any pad use) was 2%. Focal HIFU therapy for patients with clinically significant prostate cancer that has not spread has a low probability of side effects and is effective at 5 yr.
目前，临床上显著的非转移性前列腺癌（PCa）采用全腺体治疗。这种方法有效，但会有尿、性和直肠副作用。
报告聚焦高强度聚焦超声（HIFU）治疗治疗前列腺内个别部位癌症后的 5 年 PCa 控制情况。
设计、地点和参与者：这是一项对 625 例非转移性、临床上显著的 PCa 患者的前瞻性研究，这些患者在 2006 年 1 月 1 日至 2015 年 12 月 31 日期间在二级保健中心接受了聚焦 HIFU 治疗（Sonablate）。599 例患者至少有 6 个月的随访。505 例（84%）患者发现中危或高危 PCa。
使用多参数磁共振成像（mpMRI）结合靶向和系统活检或经会阴图谱活检对疾病进行定位。治疗有显著疾病的区域。随访包括前列腺特异性抗原（PSA）测定、mpMRI 和活检。
主要终点是无根治或全身治疗、转移和癌症特异性死亡率的无失败生存（FFS）。
中位随访时间为 56 个月（四分位距[IQR]35-70）。中位年龄为 65 岁（IQR61-71），术前中位 PSA 为 7.2ng/ml（IQR5.2-10.0）。1 年时 FFS 为 99%（95%CI98-100%），3 年时为 92%（95%CI90-95%），5 年时为 88%（95%CI85-91%）。对于整个患者队列，5 年时无转移、癌症特异性和总生存率分别为 98%（95%CI97-99%）、100%和 99%（95%CI97-100%）。在返回有效问卷的患者中，241/247（98%）完全无垫尿失禁，无一例需要超过 1 片/天。局限性包括缺乏长期随访。
对于有临床意义的非转移性前列腺癌的选择患者，采用高强度聚焦超声（HIFU）的局部治疗在中期是有效的，并且副作用的可能性较低。
在这项针对 625 例接受高强度聚焦超声（HIFU）局部治疗的患者的多中心研究中，无失败生存率、无转移生存率、癌症特异性生存率和总生存率分别为 88%、98%、100%和 99%。任何垫使用的尿失禁发生率为 2%。对于未扩散的有临床意义的前列腺癌患者，采用聚焦 HIFU 治疗的副作用可能性较低，5 年时效果良好。
