Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Health Technol Assess. 2018 Sep;22(52):1-96. doi: 10.3310/hta22520.
Prostate cancer (PCa) is the most common cancer in men in the UK. Patients with intermediate-risk, clinically localised disease are offered radical treatments such as surgery or radiotherapy, which can result in severe side effects. A number of alternative partial ablation (PA) technologies that may reduce treatment burden are available; however the comparative effectiveness of these techniques has never been evaluated in a randomised controlled trial (RCT).
To assess the feasibility of a RCT of PA using high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for intermediate-risk PCa and to test and optimise methods of data capture.
We carried out a prospective, multicentre, open-label feasibility study to inform the design and conduct of a future RCT, involving a QuinteT Recruitment Intervention (QRI) to understand barriers to participation.
Five NHS hospitals in England.
Men with unilateral, intermediate-risk, clinically localised PCa.
Radical prostatectomy compared with HIFU.
The randomisation of 80 men.
Findings of the QRI and assessment of data capture methods.
Eighty-seven patients consented to participate by 31 March 2017 and 82 men were randomised by 4 May 2017 (41 men to the RP arm and 41 to the HIFU arm). The QRI was conducted in two iterative phases: phase I identified a number of barriers to recruitment, including organisational challenges, lack of recruiter equipoise and difficulties communicating with patients about the study, and phase II comprised the development and delivery of tailored strategies to optimise recruitment, including group training, individual feedback and 'tips' documents. At the time of data extraction, on 10 October 2017, treatment data were available for 71 patients. Patient characteristics were similar at baseline and the rate of return of all clinical case report forms (CRFs) was 95%; the return rate of the patient-reported outcome measures (PROMs) questionnaire pack was 90.5%. Centres with specific long-standing expertise in offering HIFU as a routine NHS treatment option had lower recruitment rates (Basingstoke and Southampton) - with University College Hospital failing to enrol any participants - than centres offering HIFU in the trial context only.
Randomisation of men to a RCT comparing PA with radical treatments of the prostate is feasible. The QRI provided insights into the complexities of recruiting to this surgical trial and has highlighted a number of key lessons that are likely to be important if the study progresses to a main trial. A full RCT comparing clinical effectiveness, cost-effectiveness and quality-of-life outcomes between radical treatments and PA is now warranted.
Men recruited to the feasibility study will be followed up for 36 months in accordance with the protocol. We will design a full RCT, taking into account the lessons learnt from this study. CRFs will be streamlined, and the length and frequency of PROMs and resource use diaries will be reviewed to reduce the burden on patients and research nurses and to optimise data completeness.
Current Controlled Trials ISRCTN99760303.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 52. See the NIHR Journals Library website for further project information.
前列腺癌（PCa）是英国男性最常见的癌症。患有局部临床中期风险的患者可以选择接受根治性治疗，如手术或放疗，这可能会导致严重的副作用。目前有一些替代的部分消融（PA）技术可能会降低治疗负担，但这些技术的比较效果从未在随机对照试验（RCT）中进行过评估。
评估高强度聚焦超声（HIFU）与根治性前列腺切除术（RP）治疗局部中期 PCa 的 PA 的可行性，并测试和优化数据采集方法。
我们进行了一项前瞻性、多中心、开放性可行性研究，为未来的 RCT 设计和实施提供信息，包括 QuinteT 招募干预（QRI），以了解参与的障碍。
英国五家 NHS 医院。
单侧、局部中期、临床局限性 PCa 男性患者。
根治性前列腺切除术与 HIFU 比较。
80 名男性的随机分组。
QRI 的发现和数据采集方法的评估。
截至 2017 年 3 月 31 日，有 87 名患者同意参与，截至 2017 年 5 月 4 日，有 82 名男性被随机分组（41 名男性接受 RP 组，41 名接受 HIFU 组）。QRI 进行了两个迭代阶段：第一阶段确定了一些招募障碍，包括组织挑战、招募者平衡感缺乏以及与患者沟通研究的困难，第二阶段包括制定和实施优化招募的定制策略，包括小组培训、个人反馈和“技巧”文件。在数据提取时，即 2017 年 10 月 10 日，71 名患者的治疗数据可用。基线时患者特征相似，所有临床病例报告表（CRF）的回收率为 95%；患者报告结局测量（PROM）问卷包的回收率为 90.5%。具有提供高强度聚焦超声作为常规 NHS 治疗选择的特定长期专业知识的中心（贝辛斯托克和南安普敦）的招募率较低 - 而大学学院医院没有招募任何参与者 - 比仅在试验背景下提供 HIFU 的中心。
对 PA 与前列腺根治性治疗进行 RCT 随机分组是可行的。QRI 提供了对招募这一外科试验复杂性的深入了解，并强调了一些关键教训，如果该研究进展到主要试验，这些教训可能非常重要。现在有必要进行一项比较根治性治疗与 PA 的临床效果、成本效益和生活质量结果的全 RCT。
将按照方案对可行性研究中招募的男性进行 36 个月的随访。我们将考虑从这项研究中吸取的经验教训，设计一项完整的 RCT。CRF 将简化，PROM 和资源使用日记的长度和频率将进行审查，以减轻患者和研究护士的负担，并优化数据完整性。
当前对照试验 ISRCTN99760303。
该项目由英国国家卫生研究院（NIHR）卫生技术评估计划资助，将在；第 22 卷，第 52 期。有关该项目的更多信息，请访问 NIHR 期刊库网站。
