Pelvic fascia spARing radical prostatectomy TrIAL (PARTIAL)

项目摘要/摘要 根治性前列腺切除术(RP)是治疗局限性前列腺癌的标准治疗方法，有60,000例手术 每年在美国。公认的RP的长期不良事件包括持续性尿液 大小便失禁(~20%)和勃起功能障碍(~65%)。不太为人所知的风险包括阴茎缩短 (~50%)、阴茎畸形/曲度(~15%)、腹股沟疝气(~15%)。这些不良事件会降低健康- 相关的生活质量，导致决定后悔，需要额外的治疗。一种新的外科技术--骨盆 保留筋膜的RP(PFS-RP)，保留筋膜支持结构、阴茎的动脉供应和 在传统的RP过程中被切断和切除。几个回溯性的系列显示显著减少 PFS-RP术后排尿和勃起功能障碍。然而，这些研究规模很小，跟踪效果有限。 肿瘤学终结点。一项多中心随机对照试验(RCT)，具有更长的随访时间，显然 已注明。然而，动力充足的外科RCT面临着巨大的挑战：1)传统的RCT 新技术将花费约1000万美元；2)通常情况下，这样的随机对照试验每个中心只有大约6名患者 每年，由于应计利润较低，经常提前关闭。事实上，几乎完全没有 在肿瘤外科有足够的RCT动力。在考虑了这些挑战之后，我们开发了两个创新的 方法方法，有强有力的已公布的初步数据。第一种是使用两阶段随机对照试验 减少信息过载、决策负担和焦虑的同意。让患者更容易同意 也减轻了外科医生调查人员的负担，使他们更愿意积累。初步数据显示 两阶段同意极大地提高了收益--在最近的一项研究中，98%的符合条件的患者获得了收益 -同时保持患者对标准问卷评估的同意的理解。第二 创新采用基于网络的门户，通过向患者提供患者报告的结果来激励患者自我输入 针对他们的回答提供反馈和建议。这个门户已经被大约15,000名患者使用， 已捕获两个RCT的终结点。我们建议使用这两种新的方法论方法进行随机对照试验。这 是否将600名患者随机分为PFS-RP或传统RP，在接受NCI孢子治疗的四个中心进行 前列腺癌大奖。我们将测试PFS-RP是否能够降低排尿和勃起功能 作为直接的手术并发症，同时在癌症控制方面并不逊色。这项研究将包括一个严格的 外科医生质量保证方法，包括上传到中心站点的手术视频和量化评分 不连续的手术步骤。这项研究的成功完成不仅将为 最常见的癌症手术之一的实践，但提供了一种新的方法学方法，可以 促进未来外科肿瘤学的研究。

PROJECT SUMMARY/ABSTRACT Radical prostatectomy (RP) is a standard treatment for localized prostate cancer with 60,000 procedures per year in the U.S. Commonly recognized long-term adverse events of RP include persistent urinary incontinence (~20%) and erectile dysfunction (~65%). Less commonly known risks include penile shortening (~50%), penile deformity/curvature (~15%), and inguinal hernia (~15%). These adverse events lower health- related quality of life, cause decision regret and require additional treatment. A new surgical technique, pelvic fascia-sparing RP (PFS-RP), preserves fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional RP. Several retrospective series have shown significaly reduced urinary and erectile dysfunction after PFS-RP. However, these studies have been small and had limited follow- up for oncologic endpoints. A multi-center, randomized controlled trial (RCT) with longer follow-up is clearly indicated. However, adequately powered surgical RCTs face significant challenges: 1) a traditional RCT of this new technique would cost ~$10 million; and 2) typically, such RCTs accrue only about six patients per center per year and often close prematurely due to low accrual. Indeed, there is almost a complete absence of sufficiently powered RCTs in oncologic surgery. After considering these challenges, we developed two innovative methodological approaches that have strong published, preliminary data. The first is to use a two-stage RCT consent that lowers information overload, decisional burden, and anxiety. Making consent easier for patients also reduces the burden on surgeon investigators making them more willing to accrue. Preliminary data suggest that two-stage consent dramatically improves accrual – in one recent study, 98% of eligible patients were accrued - while maintaining patient understanding of consent as assessed by a standard questionnaire. The second innovation employs a web-based portal to incentivize self-entry of patient-reported outcomes by giving patients feedback and advice in response to their answers. This portal has already been used by ~15,000 patients and captured the endpoint for two RCTs. We propose a RCT using these two novel methodologic approaches. This will randomized 600 patients to PFS-RP or traditional RP conducted at four centers that receive NCI SPORE awards for prostate cancer. We will test whether PFS-RP is able to reduce urinary and erectile function, as well as immediate surgical complications, while being non-inferior for cancer control. The study will include a rigorous surgeon quality assurance approach, involving surgical videos uploaded to a central site and quantitative scoring of discrete surgical steps. Successful completion of the study would not only provide evidence on the best practice for one of the most common cancer operations but provide a novel methodological approach that could facilitate future studies in surgical oncology.