Focal HIFU Ablation of Prostate Cancer Using Advanced Ultrasound Guidance

描述（由申请人提供）：Riverside Research Institute （RRI）和Focus Surgery， Inc （FSI）提议建立一个学术-工业合作伙伴关系，以开发和评估指导前列腺癌活检和治疗的先进超声手段，特别是使用聚焦消融超声治疗。在美国和世界其他发达国家，这种方法在检测和治疗这种男性常见癌症方面取得了重大进展。拟议的RRI-FSI合作伙伴关系特别针对NIH计划公告PAR-07-214，“用于癌症调查的体内成像系统和方法的开发和验证”。我们寻求将RRI开发的先进的前列腺癌超声成像手段与FSI开发和制造的用于前列腺癌消融治疗的经过验证的超声仪器相结合。传统的成像方法无法区分前列腺组织的癌变和非癌变，因此，目前所有的活检和治疗方法基本上都涉及到整个腺体。通过强调超声成像和治疗癌症的联合手段，我们将克服目前的成像限制，避免目前需要消融腺体中的所有组织，并使治疗能够靶向成像癌组织。这种超声波成像和治疗方式的优雅整合代表了一种新的方法，可以更有效地治疗前列腺癌组织，同时减少不良副作用。通过提供一种有效的局部治疗手段，所提出的方法代表了前列腺癌管理的一个量子步骤。这些方法的意义延伸到一般的活检指导和任何类型的局灶性治疗，包括手术、冷冻消融和放射治疗。拟议的研究包括三个组成部分的努力：1)扩展我们现有的前列腺组织数据库，并使用经直肠12核活检组织学金标准改进我们的组织分类方法；2)采用经会阴模板引导饱和活检组织学金标准评价靶向疗效；3)开发方法来识别需要挽救治疗的放射治疗患者的活癌区域。拟议的RRI-FSI合作伙伴关系将包括国际知名的临床合作者，他们在使用RRI的组织类型成像方法和FSI的超声消融仪器方面经验丰富。我们的临床合作者隶属于华盛顿州西雅图的弗吉尼亚梅森医学中心和英国伦敦的伦敦大学学院医院。

DESCRIPTION (provided by applicant): Riverside Research Institute (RRI) and Focus Surgery, Inc. (FSI) propose an Academic-Industrial Partnership to develop and evaluate advanced ultrasonic means of guiding biopsies and treatment of prostate cancer, particularly treatment using focused ablative ultrasonic therapy. The proposed approach represents a very significant advancement in detection and treatment for this very common cancer of men in the United States and other developed countries worldwide. The proposed RRI-FSI Partnership specifically addresses NIH Program Announcement PAR-07-214, "Development and Validation of In-vivo Imaging Systems and Methods for Cancer Investigations." We seek to integrate advanced ultrasonic means of imaging prostate cancer that have been developed by RRI with a proven ultrasonic instrument that has been developed and manufactured by FSI for ablative treatment of prostate cancer. Conventional imaging methods cannot distinguish cancerous from non-cancerous prostate tissue, and consequently, all current biopsy and treatment methods essentially involve the entire gland. By emphasizing combined ultrasonic means of imaging cancer and treating it, we will overcome current imaging limitations, obviating the current need to ablate all tissue in the gland, and enabling treatment to be targeted to image cancerous tissue. This elegant integration of ultrasonic imaging and treatment modalities represents a novel approach to more-effectively treating only cancerous tissue in the prostate while reducing adverse side effects. By providing an effective means of delivering focal treatment, the proposed methods represent a quantum step forward in prostate-cancer management. The significance of these methods extends to biopsy guidance in general and to focal treatments of any type, including surgery, cryoablation, and radiation therapy. The proposed studies consist of three component efforts: 1) expanding our existing prostate-tissue data base and refining our tissue classification methods using transrectal 12-core biopsy histology gold standards; 2) evaluating targeting efficacy using transperineal template-guided saturation-biopsy histology gold standards; and 3) developing methods to identify viable cancer regions in radiation-treated patients who require salvage therapy. The proposed RRI-FSI Partnership will include internationally respected clinical collaborators who are experienced in the use of RRI's tissue-type imaging methods and FSI's ultrasonic ablation instrument. Our clinical collaborators are affiliated with the Virginia Mason Medical Center in Seattle, WA and the University College London Hospitals in London, England. PUBLIC HEALTH RELEVANCE: Riverside Research Institute and Focus Surgery, Inc. propose an Academic-Industrial Partnership to develop and evaluate advanced ultrasonic means of guiding prostate-cancer biopsies and treatment, particularly ablative ultrasonic therapy. The proposed approach represents a very significant advance in detection and therapy for this very common cancer of men in the United States and developed countries worldwide.