Department of Urology, AMC University Hospital, Amsterdam, The Netherlands.
Department of Urology, AMC University Hospital, Amsterdam, The Netherlands.
Eur Urol. 2014 Jun;65(6):1078-83. doi: 10.1016/j.eururo.2014.01.001. Epub 2014 Jan 13.
Focal therapy has been introduced for the treatment of localised prostate cancer (PCa). To provide the necessary data for consistent assessment, all focal therapy trials should be performed according to uniform, systematic pre- and post-treatment evaluation with well-defined end points and strict inclusion and exclusion criteria.
To obtain consensus on trial design for focal therapy in PCa.
DESIGN, SETTING, AND PARTICIPANTS: A four-staged consensus project based on a modified Delphi process was conducted in which 48 experts in focal therapy of PCa participated. According to this formal consensus-building method, participants were asked to fill out an iterative sequence of questionnaires to collect data on trial design. Subsequently, a consensus meeting was held in which 13 panellists discussed acquired data, clarified the results, and defined the conclusions.
A multidisciplinary board from oncologic centres worldwide reached consensus on patient selection, pretreatment assessment, evaluation of outcome, and follow-up.
Inclusion criteria for candidates in focal therapy trials are patients with prostate-specific antigen <15 ng/ml, clinical stage T1c-T2a, Gleason score 3+3 or 3+4, life expectancy of >10 yr, and any prostate volume. The optimal biopsy strategy includes transrectal ultrasound-guided biopsies to be taken between 6 mo and 12 mo after treatment. The primary objective should be focal ablation of clinically significant disease with negative biopsies at 12 mo after treatment as the primary end point.
This consensus report provides a standard for designing a feasible focal therapy trial.
A variety of ablative technologies have been introduced and applied in a focal manner for the treatment of prostate cancer (PCa). In this consensus report, an international panel of experts in the field of PCa determined pre- and post-treatment work-up for focal therapy research.
局部治疗已被引入用于治疗局限性前列腺癌（PCa）。为了提供一致评估所需的数据，所有局部治疗试验都应根据统一的、系统的治疗前后评估进行，评估具有明确的终点和严格的纳入和排除标准。
就 PCa 局部治疗试验设计达成共识。
设计、地点和参与者：采用改良 Delphi 过程的四阶段共识项目，共有 48 名 PCa 局部治疗专家参与。根据这一正式的共识建立方法，要求参与者填写一系列迭代问卷，以收集关于试验设计的数据。随后，举行了一次共识会议，13 名小组成员讨论了获得的数据，澄清了结果，并定义了结论。
来自全球肿瘤中心的多学科委员会就患者选择、治疗前评估、结果评估和随访达成了共识。
局部治疗试验候选者的纳入标准为前列腺特异性抗原（PSA）<15ng/ml、临床分期 T1c-T2a、Gleason 评分 3+3 或 3+4、预期寿命>10 年和任何前列腺体积。最佳活检策略包括在治疗后 6 至 12 个月之间进行经直肠超声引导活检。主要目标应该是用 12 个月后治疗的阴性活检来消融有临床意义的疾病。
本共识报告为设计可行的局部治疗试验提供了标准。
已经引入并以局部方式应用了多种消融技术来治疗前列腺癌（PCa）。在本共识报告中，前列腺癌领域的国际专家小组确定了局部治疗研究的治疗前后检查。
