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Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy (USA)

2016年3月11日 更新者:Beth Israel Medical Center

Phase I/II Evaluation of Cancer-Specific Imaging Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy

In standard treatment, the seeds are placed throughout the prostate to treat the entire prostate. This is done because it was impossible to know where the cancer was located within the prostate. A new technique has been developed using the same ultrasound imaging that you probably had when you had your biopsy. Using this technique, areas likely to contain prostate cancer can be identified.In this early study of 15 subjects, we will test if this method to plan your prostate seed implant is safe and can be done as part of regular care. Areas identified as suspicious for cancer will be treated with higher doses of radiation while those areas not demonstrating cancer will be treated to the standard minimum dose. The higher dose areas will receive two times the minimum dose the prostate usually receives. Because this technique is not perfect, those areas not identified as cancerous should be treated in case there is a cancer area that the technique did not identify. Subjects enrolled in this study will then be followed with this ultrasound technique over the next two years to monitor the changes to the cancerous areas and will undergo a biopsy two years after the procedure. Subjects will, of course, be monitored to assess the success of the technique and its side effects.

研究概览

详细说明

Prostate brachytherapy is an increasingly popular treatment for clinically localized prostate cancer.In properly selected patients, it is highly effective with biochemical (PSA) disease free survival rates of 80-87% at 5-10 years.However, the technique is currently limited by the inability to localize the cancer within the prostate. The multifocal nature of prostate cancer is well established. Because of the inability to know where within the prostate the cancer is located, radiation must be delivered throughout the gland. Although this blind approach leads to good results, it is clear that there are regions of the prostate and surrounding tissue that are overexposed to radiation while others are underexposed relative to their true need based on their tumor burden and their proximity to the tumor areas.Feleppa et al. at Riverside Research Institute (New York, NY), a non-profit ultrasound research center, have developed an ultrasound-based technique to identify cancer-containing areas within the prostate. This technique uses current ultrasound equipment already in use for prostate brachytherapy guidance. By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image.In this study, we propose to obtain these ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning.The primary goal of this study is to demonstrate that this imaging modality can be incorporated into the treatment planning process for brachytherapy. Furthermore, we wish to demonstrate the improved dosimetry of the cancer-identified regions while maintaining the urethral dose guidelines noted above. We also wish to compare the differences in dose to the other adjacent normal structures (anterior rectum and right and left neurovascular bundles). Additionally, we seek to demonstrate, at a minimum, no increased toxicity with this approach and similar disease control rates. Of course, ultimately the goal will be to demonstrate a superior therapeutic ratio with this technique.

研究类型

介入性

注册 (实际的)

14

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10019
        • St.Luke's-Roosevelt Hospital Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
  • PSA ≤ 10 ng/ml
  • Gleason sum on biopsy ≤ 6
  • Prostate volume ≤ 50 cc
  • Willing to continue follow-up for at least two years.

Exclusion Criteria:

  • No prior hormone therapy
  • No prior radiotherapy
  • No history of collagen vascular disease
  • No history of inflammatory bowel disease

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:pre-implant transrectal ultrasound images and planning
Transrectal ultrasound session will be performed at a separate session prior to the implant.
The technique uses current ultrasound equipment already in use for prostate brachytherapy guidance.By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image. Comparing the results with this technique to the results of prostate biopsies demonstrates a high degree of accuracy with the area under the receiver-operator characteristic curve of 0.87, a result superior to any other imaging methods.
an ultrasound-based technique to identify cancer-containing areas within the prostate.
ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning
其他名称:
  • The ultrasound unit used is the B+K Hawk 2102 with probe #8658.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
modified B+K ultrasound-based tissue-type images
大体时间:2 years
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ronald Ennis, MD、St. Luke's-Roosevelt Hospital Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年2月1日

初级完成 (实际的)

2014年8月1日

研究完成 (实际的)

2014年8月1日

研究注册日期

首次提交

2010年10月22日

首先提交符合 QC 标准的

2010年10月22日

首次发布 (估计)

2010年10月25日

研究记录更新

最后更新发布 (估计)

2016年3月14日

上次提交的符合 QC 标准的更新

2016年3月11日

最后验证

2016年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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