Accurate Prostate Cancer Diagnosis for Active Surveillance Patients Using a Novel

工程摘要 积极监测（AS）越来越被接受为低风险男性的合理治疗选择。 前列腺癌（即Gleason评分6，临床分期T2a，PSA < 10）。许多AS协议主要 研究机构要求在初步诊断后进行前列腺饱和活检，以确认患者没有区域 高危前列腺癌对于大多数接受前列腺活检的患者来说， 由于准确性有限，诊断不确定，手术时间长。前列腺活检针装置 在临床上活检不是最佳的。为了在开始AS之前更完全地对前列腺的所有区域进行采样， 通常进行经会阴途径前列腺芯活检。本研究整合了五项创新 技术，所有这些技术都被证明是可行的，以高产和准确的模板引导经会阴 饱和活检（HATB）系统。一种具有大倾角切割刃的端切活检针尖， 通过高速回缩管心针在针内产生高且即时的抽吸真空，抛光 针内表面，以减少摩擦，并应用最佳的针速，以增加组织长度， 针吸活检。使用前列腺活检常用的18号针，HATB可以持续采集40至50 mm长的组织样本。HATB系统可以在整个长度（顶点， 中间和底部）的前列腺。的 高硬度碳化钨针芯，最佳插入速度，精确会阴模板 孔可以减小偏转，从而减小电流针系统。我们之前已经证明了 这六项创新在初步产品开发测试中的可行性，并将把它们整合到 HATB系统。该产品将对那些患有前列腺癌的患者产生重大影响， 通过更准确、创伤更小和更安全的饱和前列腺活检技术，它将 也影响泌尿科医生通过提高前列腺活检的准确性来更好地诊断前列腺癌 一个程序，以获得更准确的临床分期的病人的疾病，导致更适当的治疗 选择，并最终改善前列腺癌肿瘤学结果并降低治疗成本。

Project Abstract Active surveillance (AS) is becoming more accepted as a reasonable treatment option for men with low-risk prostate cancer (i.e. Gleason score 6, clinical stage T2a, PSA < 10). Many AS protocols at major institutions call for a prostate saturation biopsy after initial diagnosis to confirm that the patient has no areas of higher-risk prostate cancer. For most patients who underwent prostate biopsy recognize it as a painful and lengthy procedure with an uncertain diagnosis due to limited accuracy. The biopsy needle devices for prostate biopsy in clinic are not optimal. To more completely sample all regions of the prostate prior to initiating AS, a transperineal approach prostate core biopsy is commonly performed. This research integrates five innovative techniques, all proven feasible individually, to a High-yield and Accurate template-guided Transperineal saturation Biopsy (HATB) system. An end-cut biopsy needle tip with high inclination angle cutting edge, the high and instant suction vacuum inside the needle created by retracting the stylet at a high speed, polished needle internal surface to reduce friction, and optimal needle speed are applied to increase the tissue length in needle biopsy. Using the 18 gage needle common for prostate biopsy, HATB can consistently acquire 40 to 50 mm long tissue sample in each pass. HATB system can acquire biopsy sample across the entire length (apex, mid and base) of the prostate in one needle insertion via the transperineal template-guided technique. The needle with high stiffness tungsten carbide stylet, optimal insertion speed, and perineal template with precision holes can reduce the deflection plaguing current needle systems. We have previously demonstrated the feasibility of these six innovations in preliminary product development tests and will integrate them into the HATB system. This product will have a significant impact on those patients with prostate cancer who are eligible for AS through a more accurate, less traumatic and safer saturation prostate biopsy technique. It will also impact Urologists to better diagnose prostate cancer by increasing the accuracy of the prostate biopsy procedure to gain more exact clinical staging of a patient's disease, leading to more appropriate treatment choices, and ultimately improving prostate cancer oncologic outcomes and reducing treatment costs.