Robot-Assisted Personalized Prostate Biopsy

项目摘要/摘要 前列腺癌是最常见的癌症类型，也是第二大致癌原因。 美国男性中的相关死亡。目前对PCA攻击性的最佳估计是获得的Gleason评分 从核心活检中提取的。最常见的活检方法是徒手经直肠超声(TRUS)引导。自.以来 超声仅能从肉眼上识别前列腺癌，而系统活检(SB)的目的是对前列腺进行均匀采样。但 徒手画SB是高度不一致的、主观性的，并导致采样不均匀，留下大片区域 未采样的前列腺，这可能导致对临床上有意义的癌症采样不足和PCa分期不足 活检时的诊断。 目前，前列腺活检的趋势是向靶向活检(TB)方向发展，该方法由 多参数磁共振成像(MpMRI)。有几种先进的活组织检查设备可供选择 将mpMRI记录(融合)到介入性超声。与SB相比，TB的PCA显着检测率更高。 但在没有mpMRI发现的患者中，SB发现许多男性患有前列腺癌，因此目前还进行了SB检查 为了结核病。然而，SB对所有患者使用相同的12核扩展六分仪计划，而不考虑他们的腺体形状。 此外，即使使用融合设备，在徒手活检时，泌尿科医生之间也存在显著的差异。 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，这种设备可以将某人从一个人带到另一个人 从适合所有人的尺寸到患者优化的计划，以及从徒手到无手技能独立机器人- 辅助手术。目前还没有类似的设备。这项技术由机器人超声波探头组成。 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。我们的 新的SB计划软件优化了每个患者的活检核心位置，以最大限度地提高可能性 检测有临床意义的前列腺癌，并考虑mpMRI可见的病变(如果有)。 该机器人装置已被美国食品和药物管理局和我们的机构审查批准进行临床试验 董事会批准了这项研究。0期，安全性和可行性临床试验顺利完成。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 精准活检在随机临床试验中提高临床有意义的PCa的检出率 市场上最常见的融合活组织检查设备之一。 这项为期5年的计划的具体目标是：1)进行机器人与融合装置的随机临床试验。 包括接受mpMRI检查的患者。在每个臂上，在PI-RADS≤2上执行SB，在PI-RADS≥3上执行TB+SB A2)记录行根治性前列腺切除术的A1组患者的病理，并比较 活检以获得双臂的前列腺切除术结果；A3)离线，模拟SB单独为患者制定计划 SB+TB，并确定SB核心是否会重叠TB位置；

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;