Pelvic fascia spARing radical prostatectomy TrIAL (PARTIAL)

保留骨盆筋膜的根治性前列腺切除术试验（部分）

• 批准号: 10366347
• 负责人: Mohamad Allaf
• 金额: $ 73.37万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-04 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10366347
• 关键词: Adverse event; Advisory Committees; Affect; African American; American; Anatomy; Anterior; Anxiety; Area; Award; Bladder; Blood Vessels; Cancer Control; Clinical Treatment; Complex; Consent; Data; Deformity; Dorsal; Erectile dysfunction; Evaluation; Event; Face; Fascia; Feedback; Funding; Future; Incentives; Informed Consent; Inguinal Hernia; Life; Location; Malignant Neoplasms; Malignant neoplasm of prostate; Methodology; Morbidity - disease rate; Nerve; Operative Surgical Procedures; Outcome; Patient Outcomes Assessments; Patient Self-Report; Patients; Pelvis; Peyronie Disease; Population; Preventive service; Procedures; Process; Prostate; Prostate-Specific Antigen; Publications; Publishing; Questionnaires; Radical Prostatectomy; Randomized; Randomized Controlled Trials; Recurrence; Regrets; Reporting; Research Personnel; Resected; Retrospective Studies; Risk; Robotics; Series; Sex Functioning; Site; Structure; Surgeon; Surgical Oncology; Surgical complication; Surgical margins; Surveys; Techniques; Testing; Time; Urinary Incontinence; abdominal wall; cancer surgery; clinically significant; cost; data portal; follow-up; health related quality of life; improved; innovation; medical complication; men; neglect; novel; novel strategies; operation; penis; postoperative recovery; premature; preservation; primary outcome; prognostic; prospective; quality assurance; repaired; research study; response; self esteem; standard care; treatment arm; trial comparing; tumor; urinary; web portal

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.

项目总结/摘要 根治性前列腺切除术（RP）是局限性前列腺癌的标准治疗方法，有60，000例手术 常见的RP长期不良事件包括持续性尿潴留， 失禁（~20%）和勃起功能障碍（~65%）。不太常见的风险包括阴茎缩短 （~50%）、阴茎畸形/弯曲（~15%）和腹股沟疝（~15%）。这些不良事件降低健康- 相关的生活质量，导致决策后悔，需要额外的治疗。一种新的手术技术，骨盆 保留筋膜RP（PFS-RP），保留筋膜支持结构，阴茎动脉供应和神经， 在常规RP中被切断并切除。几个回顾性系列显示， PFS-RP后排尿和勃起功能障碍。然而，这些研究规模很小，而且关注有限- 用于肿瘤学终点。一项随访时间较长的多中心随机对照试验（RCT）显然 指出了然而，足够有力的外科RCT面临着重大挑战：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仅招募约6名患者 经常因应计费用低而提前关闭。事实上，几乎完全没有 在肿瘤手术中有充分把握度的RCT。考虑到这些挑战，我们开发了两个创新的 方法论方法，有强大的出版物，初步数据。第一种是采用两阶段随机对照试验 同意，降低信息过载，决策负担和焦虑。让患者更容易获得同意 也减轻了外科医生研究者的负担，使他们更愿意积累。初步数据表明 两阶段同意大大提高了累积-在最近的一项研究中，98%的合格患者被累积 - 同时保持患者对同意的理解，如通过标准问卷所评估的。第二 创新采用基于网络的门户，通过向患者提供 反馈和建议，以回应他们的回答。该门户网站已被约15，000名患者使用， 捕获了两项RCT的终点。我们提出了一个随机对照试验，使用这两种新的方法。这 将600名患者随机分为PFS-RP组或传统RP组，在接受NCI SPORE的四个中心进行 前列腺癌的治疗方法我们将测试PFS-RP是否能够减少排尿和勃起功能，以及 作为直接手术并发症，同时对于癌症控制是非劣效的。这项研究将包括一个严格的 外科医生质量保证方法，包括上传到中心网站的手术视频和定量评分 不连续的手术步骤。成功完成这项研究不仅可以证明 最常见的癌症手术之一，但提供了一种新的方法， 促进外科肿瘤学的未来研究。