Evaluation of MRI-controlled transurethral ultrasound therapy for the treatment o

MRI控制下经尿道超声治疗治疗的评价

• 批准号: 8129114
• 负责人: Rajiv Chopra
• 金额: $ 21.97万
• 依托单位: SUNNYBROOK & WOMEN'S COLL HLTH SCIS CTR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8129114
• 关键词: Adoption; Age; Biopsy Specimen; Canis familiaris; Clinical; Coagulation Process; Detection; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Diagnostic Imaging; Disease; Ensure; Evaluation; Excision; Future; Gland; Goals; Heating; High Prevalence; High temperature of physical object; Histology; Human; Image; Impairment; Indolent; Intestines; Lead; Left; Lesion; Local Therapy; Location; Magnetic Resonance; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Methods; Monitor; Morbidity - disease rate; Normal tissue morphology; Operative Surgical Procedures; Outpatients; PSA screening; Pilot Projects; Procedures; Prostate; Prostatic Neoplasms; Quality of life; Radical Prostatectomy; Research; Research Design; Risk; Schedule; Screening procedure; Specific qualifier value; Staging; Technology; Temperature; Testing; Time; Tissues; Treatment Effectiveness; Ultrasonic Therapy; Urethra; base; cancer diagnosis; cancer therapy; clinically significant; conventional therapy; disorder risk; effective therapy; indexing; insight; men; minimally invasive; new technology; pre-clinical; simulation; tumor; urinary

DESCRIPTION (provided by applicant): Contemporary screening methods for prostate cancer have resulted in an increase in the proportion of men detected with low- to intermediate-risk disease, and a decrease in the average age of detection, compared to previous decades. Unfortunately, current detection methods largely based on biopsy, sample less than 1% of the volume of the prostate and provide little information about the exact location and size of the cancer within the gland. As a result, treatments for localized prostate cancer target the entire prostate gland, which is effective at eliminating disease, but leaves many men with long-term complications to sexual, urinary, and bowel function. Diagnostic imaging with MRI has advanced in recent years to the point where it is possible to see the location and size of tumours within the prostate gland. In addition, the development of new ways to treat prostate cancer under image-guidance offer the promise of more precise treatments with the potential for reduced complications. In this proposal, the ability of MRI-controlled transurethral ultrasound therapy to treat localized prostate cancer will be evaluated. This technology involves treatment (through high temperatures) of specified regions in the prostate gland using high-intensity ultrasound energy delivered from a device inserted into the urethra. The unique feature of this treatment is that it is performed entirely within a magnetic resonance imager, which provides non-invasive images of the temperature within the prostate during heating. This integration of heating and temperature monitoring enables very precise treatment of tissue within the gland. The overall goal of this research is to transform the treatment of localized prostate cancer into a minimally- invasive, outpatient procedure that is as effective as current treatments, but has much lower complications associated with it. The goal of this proposal will be to evaluate the ability of MRI-controlled transurethral ultrasound therapy to effectively treat localized prostate cancer detected with diagnostic MRI. This study will be performed in men scheduled for surgery, so their prostate glands can be studied after removal to evaluate the effectiveness of the treatment. This study design is necessary to ensure a safe evaluation of this novel technology which was tested recently for the first time in humans by our group. If successful, the proposed study will demonstrate the ability of this technology to be used to treat prostate cancer effectively, paving the way for future studies comparing this technology with existing treatments for localized prostate cancer. PUBLIC HEALTH RELEVANCE: Due to widespread adoption of PSA testing, the majority of men with prostate cancer are diagnosed at earlier stages of disease development, and at a younger age. Conventional treatments for low- to intermediate-risk localized prostate cancer are effective, but leave many men with long-term impairment of sexual, urinary and bowel function. The goal of this research is to develop a minimally-invasive, image-guided treatment for localized prostate cancer that is as effective as radical treatments, but with reduced adverse quality of life effects. Given the high prevalence of indolent disease and the high morbidity of conventional treatment approaches, this treatment would have a significant positive impact on the quality of life of a large proportion of men treated for prostate cancer.

描述（由申请人提供）：与前几十年相比，现代前列腺癌的筛查方法导致了低至中等风险疾病检测到的男性比例的增加，而平均检测年龄的降低也有所下降。不幸的是，当前的检测方法主要基于活检，样本不到前列腺体积的1％，几乎没有关于腺体内癌症的确切位置和大小的信息。结果，对局部前列腺癌的治疗方法是整个前列腺，这有效地消除了疾病，但许多男性长期存在性，尿和肠功能。近年来，使用MRI的诊断成像已提高到可以看到前列腺内肿瘤的位置和大小的地步。此外，在图像引导下治疗前列腺癌的新方法的发展提供了更精确的治疗方法，并有可能减少并发症。在此提案中，将评估MRI控制的经尿道超声治疗治疗局部前列腺癌的能力。该技术涉及使用从插入尿道的设备传递的高强度超声能量（通过高温）对前列腺中指定区域的处理。该处理的独特特征是它完全在磁共振成像仪中执行，该图像在加热过程中提供了前列腺内温度的无创图像。加热和温度监测的这种整合可以非常精确地处理腺体内的组织。这项研究的总体目标是将局部前列腺癌的治疗转变为一种与当前治疗一样有效的微创门诊手术，但与之相关的并发症较低。该提案的目的是评估MRI控制的尿道超声治疗能够有效治疗用诊断MRI检测到的局部前列腺癌的能力。这项研究将在计划进行手术的男性中进行，因此可以在切除后研究其前列腺以评估治疗的有效性。这项研究设计对于确保对这项新技术的安全评估是必要的，该技术最近在我们的小组中首次在人类中进行了测试。如果成功，拟议的研究将证明该技术可用于有效治疗前列腺癌的能力，为将来的研究铺平了将这项技术与现有治疗局部前列腺癌进行比较的方法。 公共卫生相关性：由于PSA测试的广泛采用，大多数前列腺癌患者在疾病发展的早期阶段被诊断出来。低至中等风险的局部前列腺癌的常规治疗方法有效，但使许多男性长期损害性，尿和肠功能。这项研究的目的是开发一种对局部前列腺癌的微创，图像引导的治疗方法，该治疗与激进治疗一样有效，但降低了生活质量的影响。鉴于懒惰疾病的高患病率和常规治疗方法的高发病率，这种治疗将对大量治疗前列腺癌的男性的生活质量产生重大积极影响。