Evaluation of Transperineal Biopsy under Local Anesthesia, a Novel approach to Decrease Post-Biopsy Infections and Improve Cancer Detection

局部麻醉下经会阴活检的评估，一种减少活检后感染和改善癌症检测的新方法

• 批准号: 10475296
• 负责人: Mohamad Allaf
• 金额: $ 65.29万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-11 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10475296
• 关键词: Address; Adopted; Adoption; Adverse event; African American; Anterior; Antibiotic Prophylaxis; Antibiotic Resistance; Antimicrobial Resistance; Attenuated; Bacteremia; Bacteria; Bacteriuria; Biopsy; Cancer Detection; Clinic; Collaborations; Data; Detection; Diagnosis; Diffusion; Environment; Equipoise; Evaluation; Funding; General Anesthesia; Gold; Guidelines; Hemorrhage; Hospital Costs; Hospitalization; Individual; Infection; Lesion; Local Anesthetics; Local anesthesia; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Medicare; Needles; Outcome; Pain; Patients; Pelvic floor structure; Population Heterogeneity; Prevalence; Problem Solving; Procedures; Prophylactic treatment; Prospective Studies; Prostate; Public Health; Randomized Controlled Trials; Rectum; Research; Research Personnel; Risk; Sampling; Screening for Prostate Cancer; Sepsis; Skin; Sterility; Techniques; Time; Transrectal Ultrasound; Ultrasonography; Urinary Retention; Urinary tract; accurate diagnosis; antimicrobial; base; clinically significant; cost; experience; improved; infection rate; infection risk; innovation; men; mortality; novel; novel strategies; prostate biopsy; racial disparity; randomized trial; rectal; standard of care; stem; tumor; ultrasound

PROJECT SUMMARY/ABSTRACT Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy (Bx) performed annually in the U.S. Almost all Bx are performed as an office based procedure in under 15 minutes. The precision of Bx has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate. However, significant limitations remain with this approach, including a significantly increasing risk of post-Bx infection. This arises because more than 97% of all prostate Bx are performed via a transrectal (TR) approach that introduces rectal bacteria with each pass of the Bx needle into the sterile urinary tract. The current risk of post-TR Bx infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually. Transperineal (TP) Bx is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the Bx needle through the perineal skin and pelvic floor. TP Bx has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second when TR Bx was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge. Beyond the potential for in-office TP Bx to significantly reduce or eliminate Bx infections, TP Bx may also improve cancer detection as studies of TP Bx (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to TR Bx. This is notable as anterior tumors are difficult to sample with TR Bx. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers. Although TR Bx is used widely, it is associated with a significant and increasing risk of Bx infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate Bx. We have refined a TP Bx approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. We hypothesize that TP MRI targeted Bx will: (1) largely eliminate post-Bx infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to TR MRI targeted Bx; and (3) have significantly better detection of prostate cancer. A multi-center randomized controlled trial will be conducted to evaluate in-office TP MRI targeted vs. TR MRI targeted Bx, the current gold standard. This has transformative impact to change current standard of practice. The investigators have a track record for collaboration. The environment comprises 4 high-volume, SPORE funded centers of excellence that serve diverse populations.

项目摘要/摘要 前列腺癌是美国男性最常见的恶性肿瘤。大约有1个 美国每年进行百万次前列腺活检(Bx)。几乎所有Bx都是在办公室进行的 程序在15分钟内完成。在过去的十年里，随着Bx的引入，Bx的精度得到了提高 核磁共振引导/定位前列腺内的可疑病变。然而，仍然存在着显著的限制 这种方法包括显著增加Bx后感染的风险。这是因为97%以上的人 在所有前列腺癌中，Bx是通过经直肠(TR)途径进行的，每次通过时都会引入直肠细菌 将Bx针头插入无菌尿路。即使使用抗菌药，目前仍有感染Bx病毒后的风险 预防的比例很高，总体上约为7%，每年需要住院的男性比例为3%(3万人)。 经会阴(TP)Bx是一种替代方法，它消除了细菌从 直肠到前列腺。这种方法是在没有抗菌预防的情况下执行的，而是通过 BX针刺穿会阴皮肤和盆底。由于几个原因，TP Bx尚未被广泛采用。 从历史上看，它被认为对临床上的患者来说太痛苦了，因此传统上是这样做的 在全身麻醉下。增加的时间、不便和成本限制了它在全国范围内的采用。 其次，在40多年前首次采用TRBx时，直肠菌群的抗生素耐药性还不是一种 挑战。除了办公室内TP Bx显著减少或消除Bx感染的潜力外，TP Bx还可能 也改善了癌症检测，因为TP Bx(在全身麻醉下进行)的研究表明 与TRBx相比，前列腺癌的检测率更高，尤其是前区肿瘤。 这是值得注意的，因为前部肿瘤很难用TRBx进行采样。前部肿瘤也有两倍的可能性 发生在非裔美国人男性身上。事实上，我们的研究表明，一些结果差异在 非洲裔美国男性可能源于前列腺癌前病变的漏诊。尽管TRBx是 广泛使用，它与Bx感染的显著和增加的风险有关，因为 抗生素耐药性，突显出迫切需要一种更安全的替代方法来治疗前列腺癌Bx。 我们在局部麻醉下改进了一种TP Bx入路，在没有MRI靶向/引导的情况下 预防性使用抗生素的必要性。我们假设靶向Bx的TP MRI将：(1)基本上消除 Bx后感染和因尿毒症而住院的费用高昂；(2)在办公室进行类似的 与以Bx为靶点的TRMRI相比，不适和非感染性并发症；以及(3)显著 更好地检测前列腺癌。将进行多中心随机对照试验，以 评估办公室内针对TP的MRI与针对Bx的TR MRI，这是当前的黄金标准。这具有变革性 对改变现行业务标准的影响。调查人员在合作方面有过往记录。这个 环境由4个高容量、由孢子资助的卓越中心组成，服务于不同的人群。