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: 10261374
• 负责人: Mohamad Allaf
• 金额: $ 66.76万
• 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/10261374
• 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

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.

项目总结/摘要 前列腺癌是美国男性中最常见的恶性肿瘤。大约有1 在美国，每年进行的前列腺活检（Bx）约有100万例。几乎所有Bx都是在诊所进行的 在15分钟内完成手术。在过去十年中，Bx的精度随着 前列腺内可疑病变的MRI引导/靶向。然而， 这种方法，包括显着增加的风险后Bx感染。这是因为超过97%的 所有前列腺Bx均通过经直肠（TR）入路进行，每次通过均引入直肠细菌 插入无菌尿道即使使用抗菌剂，TR Bx后感染的当前风险 预防性治疗的比例很高，总体约为7%，其中3%（30，000名男性）每年需要住院治疗。 经会阴（TP）Bx是一种替代方法，可消除从会阴直接引入细菌。 直肠到前列腺这种方法，这是执行没有抗菌预防，而是通过了 bx针穿过会阴皮肤和骨盆底。TP Bx没有被广泛采用有几个原因。 从历史上看，它被认为是太痛苦的病人在诊所，因此传统上进行 在全身麻醉下增加的时间、不便和成本限制了它在全国的采用。 第二，当TR Bx在40多年前首次被采用时，直肠植物群的抗生素耐药性并不是一个重要因素。 挑战.除了诊室内TP Bx显著减少或消除Bx感染的潜力外，TP Bx可能 还可以提高癌症检测，因为TP Bx（在全身麻醉下进行）的研究表明， 与TR Bx相比，前列腺癌的检出率更高，尤其是前区肿瘤。 这是值得注意的，因为前部肿瘤难以用TR Bx取样。前部肿瘤也有两倍的可能性 发生在非裔美国人身上。事实上，我们的研究表明，一些结果的差异， 非洲裔美国人可能源于前前列腺癌的诊断不足。虽然TR BX是 广泛使用，它与Bx感染的显著和增加的风险相关， 抗生素耐药性，强调迫切需要一种更安全的替代方法来治疗前列腺Bx。 我们已经在局部麻醉下使用MRI靶向/引导改进了TP Bx方法， 抗生素预防的必要性。我们假设TP MRI靶向Bx将：（1）在很大程度上消除 Bx后感染和昂贵的尿脓毒症住院治疗;（2）在办公室进行， 与TR MRI靶向Bx相比，不适和非感染性并发症;以及（3）具有显著 更好地检测前列腺癌。将进行多中心随机对照试验， 评价诊室内TP MRI靶向与TR MRI靶向Bx（当前的金标准）。这具有变革性 影响，以改变目前的做法标准。调查人员有合作的记录。的 环境包括4个高容量，SPORE资助的卓越中心，为不同人群提供服务。