MR Guided Laser Ablation of Prostate Cancer: Phase II Trial

MR 引导激光消融前列腺癌：II 期试验

• 批准号: 8606448
• 负责人: Scott E Eggener
• 金额: $ 31.8万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-02-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8606448
• 关键词: Ablation; Adverse effects; Aftercare; American; Anatomy; Area; Biopsy; Cancer Control; Cancer Etiology; Cessation of life; Chicago; Clinical; Clinical Trials; Comorbidity; Diagnosis; Diffusion weighted imaging; Disease; Effectiveness; Erectile dysfunction; Excision; Exhibits; Gland; Goals; Hormonal; Image; Impotence; Incontinence; Injury; Judgment; Lasers; Life; Longevity; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Methods; Metric; Monitor; Newly Diagnosed; Normal tissue morphology; Oncologist; Operative Surgical Procedures; Patients; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Procedures; Prostate; Prostate Cancer therapy; Prostatectomy; Quality of life; Questionnaires; Radiation; Radiation therapy; Radical Prostatectomy; Radiosurgery; Research Personnel; Resolution; Risk; Role; Safety; Scientist; Sex Functioning; Side; Staging; Structure of base of prostate; System; Techniques; Thermography; Time; Tissues; Toxic effect; Treatment Effectiveness; Universities; Weight; alternative treatment; arm; base; breast lumpectomy; cancer therapy; comparative effectiveness; design; disorder risk; experience; follow-up; high risk; imaging modality; instrument; malignant breast neoplasm; men; migration; minimal risk; minimally invasive; phase 1 study; prevent; public health relevance; radiologist; rectal; research clinical testing; response; screening; soft tissue; standard care; treatment planning; urinary; urologic

DESCRIPTION (provided by applicant): Prostate cancer is a major cause of cancer related deaths in American men. Standard treatment of prostate cancer has been whole-gland treatment including radical prostatectomy and radiation therapy. There is growing evidence that prostate cancer is over-treated and prostate cancer may not be clinically evident during the natural life span of many patients who are aggressively treated. Whole-gland treatment methods have also been associated with high risk of complications altering quality of life such as incontinence and impotence. Based on these facts, focal treatment methods which are not associated with serious complications but aim to control the cancer at the outset have been suggested as alternative treatment methods for low-risk prostate cancer. Among these methods, MRI guided laser induced thermal therapy (LITT) is a promising technique with certain advantages over the other focal therapy methods. It can create accurate, predictable and reproducible ablation zones within the prostate and induces minimal change outside the targeted ablation zone. It is compatible with MRI and therefore, can benefit from superior soft tissue contrast resolution for treatment planning and MR thermography for real time therapy monitoring. Our group has recently completed a Phase I study and demonstrated the technical feasibility and confirmed the initial safety of this procedure. The goal of the present proposal is to conduct a phase II clinical trial with MRI-guided LITT for targeted focal destruction of prostat cancer. We hypothesize that MR-guided LITT will effectively ablate target areas of prostate cancer, exhibit an exceptional long term safety profile, and will not alter urinary or sexual qualiy-of-life. The specific aims are (1) We will conduct a Phase II non-randomized, single-arm clinical trial to rigorously assess oncologic effectiveness of MRI guided LITT in patients with newly diagnosed prostate cancer. Primary endpoint will be confirmation of lack of cancer within the treatment zone by an MR guided biopsy performed 3 months after laser ablation. Secondary endpoints will be oncologic efficacy based on biopsy of the treatment zone at 12 months following treatment and treatment-related safety and toxicity measured with validated instruments. (2) We will implement quantitative and anatomic MR imaging to follow each treated region and surrounding tissue to define alterations in the MR imaging features of the ablation zone. Dynamic contrast enhanced (DCE) imaging, diffusion weighted imaging (DWI), quantitative T2-weighted imaging and high resolution anatomic imaging will be collected prior to treatment and at 3 months and 12 months following treatment. The results of post-treatment MRI's will be compared to biopsies performed at 3 months and 12 months following the procedure. At the completion of this project, we will have treated 27 patients using MR-guided LITT and will have gained highly valuable information regarding oncologic efficacy, safety, and predictive role of MRI. We will subsequently use these results to support the design of a larger multi-center trial to evaluate the comparative effectiveness of this new focal treatment paradigm.

描述（由申请人提供）：前列腺癌是美国男性癌症相关死亡的主要原因。前列腺癌的标准治疗是全腺体治疗，包括根治性前列腺切除术和放射治疗。越来越多的证据表明，前列腺癌被过度治疗，并且在许多积极治疗的患者的自然寿命期间，前列腺癌可能在临床上并不明显。全腺体治疗方法也与改变生活质量的并发症的高风险有关，如失禁和阳痿。基于这些事实，与严重并发症无关但旨在从一开始就控制癌症的局部治疗方法已被建议作为低风险前列腺癌的替代治疗方法。在这些方法中，MRI引导的激光诱导热治疗（LITT）是一种很有前途的技术，与其他聚焦治疗方法相比具有一定的优势。它可以在前列腺内创建准确、可预测和可再现的消融区域，并在靶向消融区域外引起最小的变化。它与MRI兼容，因此，可以受益于用于治疗计划的上级软组织对比度分辨率和用于真实的时间治疗监测的MR热成像。我们的团队最近完成了一项I期研究，证明了技术的可行性，并确认了该手术的初步安全性。本提案的目标是 进行MRI引导下LITT靶向病灶破坏前列腺癌的II期临床试验。我们假设MR引导的LITT将有效消融前列腺癌的靶区域，表现出特殊的长期安全性，并且不会改变泌尿或性生活质量。具体目标是（1）我们将进行一项II期非随机、单组临床试验，以严格评估MRI引导下LITT在新诊断前列腺癌患者中的肿瘤学有效性。主要终点将是通过激光消融后3个月进行的MR引导活检确认治疗区内没有癌症。次要终点将是基于治疗后12个月治疗区活检的肿瘤学疗效，以及使用经验证的仪器测量的治疗相关安全性和毒性。(2)我们将实施定量和解剖MR成像，跟踪每个治疗区域和周围组织，以确定消融区MR成像特征的变化。将在治疗前和治疗后3个月和12个月收集动态对比增强（DCE）成像、弥散加权成像（DWI）、定量T2加权成像和高分辨率解剖成像。将治疗后MRI的结果与术后3个月和12个月进行的活检进行比较。在该项目完成时，我们将使用MR引导的LITT治疗27例患者，并将获得关于MRI的肿瘤学疗效、安全性和预测作用的非常有价值的信息。我们随后将使用这些结果来支持设计一个更大的多中心试验，以评估这种新的局部治疗模式的比较有效性。