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: 9973695
• 负责人: Mohamad Allaf
• 金额: $ 73.78万
• 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/9973695
• 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 每年在美国每年进行的百万个前列腺活检（BX）几乎所有BX都以办公室为基础 在15分钟内进行程序。在过去的十年中，BX的精度提高了 MRI指导/靶向前列腺内可疑病变。但是，仍然存在重大限制 这种方法，包括大大增加了BX后感染的风险。这是因为超过97％ 所有前列腺BX的中直直直直（TR）方法，该方法在每次通过时引入直肠细菌 BX针进入无菌尿路。当前TR后BX感染的风险，即使有抗菌素 预防量高约7％，每年需要住院3％（30,000名男性）。 跨性质（TP）BX是一种替代方法，可以消除直接引入细菌从 直肠与前列腺。这种方法是在没有抗菌预防的情况下完善的，而是通过 BX针穿过会阴皮肤和骨盆底。由于多种原因，TP BX并未被广泛采用。 从历史上看，它被认为对诊所的患者来说太痛苦了，因此传统上进行了 在全身麻醉下。增加的时间，不便和成本限制了其全国收养。 第二，当TR BX最初在40年前采用时，直肠菌群的抗生素耐药性不是 挑战。在办公室内TP BX显着减少或消除BX感染的潜力之外，TP BX可能 随着TP BX的研究（在全身麻醉下进行）也改善了癌症的检测证明 与TR BX相比，前列腺癌的检测率更高，尤其是前区域肿瘤。 这是值得注意的，因为前肿瘤很难用TR BX采样。前肿瘤的可能性也两倍 发生在非裔美国人中。实际上，我们的研究表明，某些结果差异 非裔美国人可能源于前列腺前癌的诊断不足。虽然TR BX是 使用广泛使用，它与由于增长而引起的BX感染风险的显着和增加有关 抗生素耐药性强调了迫切需要采用更安全的前列腺BX替代方法。 我们已经在局部麻醉下完善了TP BX方法，没有MRI靶向/指导 需要预防抗生素。我们假设针对BX的TP MRI将：（1）大大消除 BX后感染和尿素的昂贵住院治疗； （2）在办公室里进行类似 与靶向的BX相比，不适和非感染并发症； （3）显着 更好地检测前列腺癌。多中心随机对照试验将进行 评估靶向与TR MRI目标BX（当前的金标准）的Office TP MRI目标。这具有变革性 影响当前的实践标准。调查人员有合作的记录。这 环境包括4个大量，孢子资助的卓越中心，为各种人群提供服务。