Department of Urology, Fuerth Hospital, Fuerth, Germany.
Prostate Cancer Prostatic Dis. 2012 Sep;15(3):256-9. doi: 10.1038/pcan.2012.10.
To analyze data on patients with localized prostate cancer who were treated with complete high-intensity focused ultrasound (HIFU) prospectively captured within a voluntary HIFU user database (@-Registry).
The @-Registry includes data from consecutive patients treated with Ablatherm (EDAP-TMS) HIFU at nine European Centres during the period 1994 and 2009. For this analysis, the data repository was reviewed for information on patients with localized prostate cancer (T1 -- T2) treated with complete (whole-gland) HIFU on the basis of an anterior-posterior prostate height of ≤24 mm and a treated volume >120% of the prostate volume. Patients were regularly followed with PSA measurement and biopsy. Biochemical failure was defined for this study as PSA nadir +2 ngml(-1) (Phoenix definition). Disease-free survival was based on a biopsy, retreatment and biochemical data. Patients were risk group-stratified using the D'Amico classification system.
The median follow-up was 2.8 years for the 356 patients included in the analysis. The majority could be classified as either low (44.9%) or intermediate risk (39.6%); 14.6% patients were classified as high risk. The median (mean, s.d.) PSA nadir was 0.11 ng ml(-1) (0.78 and 3.6), achieved at a mean (s.d.) of 14.4 (11.6) weeks after HIFU. Follow-up biopsies on 226/356 (63.5%) patients revealed an overall negative biopsy rate of 80.5% (182/226); there was no statistically significant difference in positive biopsy rate by risk group-stratification. Actuarial freedom from biochemical recurrence at 5 and 7 years according to the Phoenix definition was 85% and 79%, respectively. Disease-free progression rates at 5 and 7 years were 64% and 54%, respectively.
Whole-gland prostate HIFU as primary monotherapy for localized prostate cancer achieves a recurrence-free survival in short-term analysis as assessed by prostate biopsy and serum PSA endpoints in a majority of patients.
分析前瞻性采集于自愿高强度聚焦超声（HIFU）用户数据库（@-Registry）的局限性前列腺癌患者数据。
@-Registry 纳入了 1994 年至 2009 年间欧洲 9 个中心使用 Ablatherm（EDAP-TMS）HIFU 治疗的连续患者的数据。基于前列腺前后高度≤24mm 和治疗体积超过前列腺体积 120%，对该数据库进行了回顾，以获取局限性前列腺癌（T1-T2）患者的完整（全腺体）HIFU 治疗信息。定期对患者进行 PSA 测量和活检随访。本研究将 PSA 最低值增加 2ng/ml（Phoenix 定义）定义为生化失败。无病生存率基于活检、复发和生化数据。采用 D'Amico 分类系统对患者进行风险分层。
纳入分析的 356 例患者的中位随访时间为 2.8 年。大多数患者可分为低危（44.9%）或中危（39.6%）；14.6%的患者为高危。中位（平均，标准差）PSA 最低值为 0.11ng/ml（0.78 和 3.6），在 HIFU 后平均（标准差）14.4（11.6）周达到。对 356 例患者中的 226 例（63.5%）进行了随访活检，总体阴性活检率为 80.5%（182/226）；各风险分层组的阳性活检率无统计学差异。根据 Phoenix 定义，5 年和 7 年时生化无复发生存率分别为 85%和 79%。5 年和 7 年时无疾病进展率分别为 64%和 54%。
局限性前列腺癌的全腺体前列腺 HIFU 作为单一原发性治疗，在短期分析中通过前列腺活检和血清 PSA 终点评估，大多数患者可达到无复发生存。
