Robot-Assisted Personalized Prostate Biopsy

项目总结/摘要 前列腺癌（PCa）是最常见的癌症类型，也是第二大癌症原因 美国男性相关死亡目前对PCa侵袭性的最佳估计是获得的Gleason评分， 组织活检的结果最常见的活检方法是徒手经直肠超声（TRUS）引导。以来 超声仅很少在视觉上识别PCa，系统活检（SB）旨在均匀地对前列腺取样。但 徒手SB是高度不一致的、主观的，并且导致不均匀的采样，留下大区域的 前列腺未采样，这可能导致临床显著癌症的采样不足和PCa分期不足 活检诊断。 前列腺活检的当前趋势是导向靶向活检（TB）方法， 多参数磁共振成像（mpMRI）。有几种先进的活检设备可用， 将mpMRI配准（融合）到介入超声。TB产生比SB更高的显著PCa检出率。 但是SB在没有mpMRI结果的患者中发现许多男性患有PCa，因此SB目前还在进行 肺结核然而，SB对所有患者使用相同的12芯扩展六分仪计划，无论其腺体形状如何。 此外，在徒手活检时，即使使用融合器械，泌尿科医生之间也存在显著差异。 我们的团队已经开发并测试了一种新型机器人设备的可行性，该设备将SB从一个- 从一刀切到患者优化计划，从徒手到免提技能独立机器人- 辅助程序。目前不存在类似器械。这项技术包括一个机器人超声探头 用于超声处理、机器人控制、融合TB和优化SB规划的机械手和软件。我们 新型SB计划软件优化了每位患者的活检核心位置， 检测具有临床意义的PCa，并考虑mpMRI可见病变（如适用）。 该机器人设备已通过食品和药物管理局和我们的机构审查的临床试验 董事会批准了这项研究。一项0期、安全性和可行性临床试验已成功完成。我们 提出一项I期临床试验，以获得个性化活检计划有效性的早期证据， 在随机临床试验中，精确活检可提高临床显著PCa的检出率， 市场上最常见的融合活检器械之一。 该5年项目的具体目标是：A1）进行机器人与融合器的随机临床试验。 纳入接受mpMRI检查的患者。在每组中，对PI-RADS ≤ 2进行SB，对PI-RADS ≥ 3进行TB + SB A2）记录进行根治性膀胱切除术的A1患者亚组的病理学，并比较 两组的活检至直肠切除术结果; A3）离线，模拟接受手术的患者的单独SB计划 SB + TB并确定SB核是否可以与TB位置重叠;

PROJECT SUMMARY/ABSTRACT Prostate cancer (PCa) is the most commonly diagnosed type of cancer and the second leading cause of cancer related death among US men. The best current estimate of PCa aggressiveness is the Gleason score obtained from core biopsy. The most common biopsy method is freehand transrectal ultrasound (TRUS) guided. Since ultrasound only rarely identifies PCa visually, systematic biopsy (SB) intends to sample the prostate evenly. But freehand SB is highly inconsistent, subjective, and results in uneven sampling, leaving large regions of the prostate unsampled, which can lead to under-sampling of clinically significant cancer and under-staging of PCa diagnosis at biopsy. The current trend in prostate biopsy is directed towards a targeted biopsy (TB) approach guided by multiparametric Magnetic Resonance Imaging (mpMRI). Several advanced biopsy devices are available and register (fuse) the mpMRI to interventional ultrasound. TB yield a higher significant PCa detection rate than SB. But SB on patients with no mpMRI findings found many men to harbor PCa, so SB is currently performed in addition to TB. However, SB use the same 12-core extended sextant plan for all patients regardless of their gland shape. Moreover, significant variability exists among urologists at freehand biopsy, even with the fusion devices. Our team has developed and tested the feasibility of a novel robotic device that takes SB from a one- size-fits-all to a patient-optimized plan, and from a freehand to a hands-free skill-independent robot- assisted procedure. No similar devices currently exist. This technology consists of a robotic ultrasound probe manipulator and software for ultrasound processing, robot control, fusion TB, and optimized SB planning. Our novel SB planning software optimizes the biopsy core locations for each patient to maximize the likelihood of detecting clinically significant PCa and taking into account mpMRI visible lesions, if available. The robotic device was cleared for clinical trials by the Food and Drug Administration and our Institutional Review Board approved the study. A Phase 0, Safety and Feasibility clinical trial was successfully completed. We propose a Phase I clinical trial to gain early evidence on the effectiveness of personalized biopsy planning and precision biopsy to improve the detection rate of clinically significant PCa in a randomized clinical trial versus one of the most common fusion biopsy devices on the market. The specific aims of the 5-year project are: A1) Perform randomized clinical trial of robot vs. the fusion device. Include patients with mpMRI exams. On each arm, perform SB on PI-RADS≤2 and TB+SB on PI-RADS≥3 patients; A2) Record pathology from subset of patients of A1 who proceed to radical prostatectomy, and compare biopsy to prostatectomy results on both arms; A3) Offline, simulate SB alone plans for patients who undergo SB+TB and determine if SB cores could overlap TB locations;