此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Prolaris Enhanced Risk Stratification - an ecONomic and clinicAL Evaluation (PERSONAL)

2019年2月26日 更新者:The Leeds Teaching Hospitals NHS Trust

One in 8 men will be diagnosed with prostate cancer during their lifetime. The majority of men diagnosed with prostate cancer have early stage disease, which can be managed in a variety of ways, ranging from monitoring to international treatment. However is it not always clear which treatment option is best.

All men with newly diagnosed localised prostate cancer are assigned a disease risk category (low/intermediate/high risk). This is based on clinical findings and prostate biopsy results, but these factors are limited in their ability to distinguish between aggressive and indolent prostate cancers. The current risk grouping can make it difficult to plan appropriate treatment tailored and personalised to the individual patient.

There is evidence reporting overtreatment of localised prostate cancer in the UK. However, many patients with aggressive disease are wrongly assigned a low risk categorisation and are recommended surveillance when better suited to more interventional treatment.

Myriad Genetics have developed a test, called Prolaris which measures how fast cells in a prostate cancer are dividing to assess its aggressiveness. The Prolaris test is performed on routine prostate biopsy tissue, so patients are not subjected to any additional invasive investigations.

In this study, led by Leeds Teaching Hospitals NHS Trust, the aim is find out if the Prolaris® test score helps patients with newly diagnosed prostate cancer and their clinical team make better informed treatment choices that are tailored to the individual patient.

The aim to achieve a Prolaris risk score for 100 patients and determine the impact it has on treatment decision making. The research team will look at how the test fits into routine clinical practice, investigate the clinician and patient views and understanding on the test report and assess the quality of life of patients in the different risk and treatment groups.

研究概览

地位

未知

条件

研究类型

观察性的

注册 (预期的)

100

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

    • West Yorkshire
      • Leeds、West Yorkshire、英国、LS9 7TF
        • 招聘中
        • St James's University Hospitals NHS Trust
        • 接触:
          • William Cross, MRCS

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 至 100年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

男性

取样方法

概率样本

研究人群

Men who have a diagnosis of prostate cancer on their prostate biopsy.

描述

Inclusion Criteria:

  • Clinical suspicion of prostate cancer
  • Able to provide informed written consent
  • No contraindication to prostate biopsy
  • Newly diagnosed treatment-naive patient with histologically proven localised adenocarcinoma of the prostate
  • Low or intermediate D'Amico risk prostate cancer
  • Sufficient quantity and quality of tissue remains from biopsy to perform genomic testing
  • No contraindication to radical treatment if diagnosed with localised prostate cancer
  • Estimated life expectancy >10 years

Exclusion Criteria:

  • Men with locally advanced, clinical node positive or metastatic disease
  • Patients who lack capacity to consent to study participation
  • Non-adenocarcinoma prostate cancer histology

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prolaris test outcome received via report.
大体时间:30-60mins
Results of the test received.
30-60mins
Treatment counselling
大体时间:30-60mins
Feedback of the results of the prolaris test. Consultant Urologist will see each participant in clinic after receipt of the Prolaris test report. They will explain the results to the patient and the patient will have the opportunity to ask any questions that they may have. The patient will then be able to decide on their treatment option.
30-60mins

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。

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 (实际的)

2019年2月21日

初级完成 (预期的)

2020年10月30日

研究完成 (预期的)

2020年10月30日

研究注册日期

首次提交

2019年2月21日

首先提交符合 QC 标准的

2019年2月21日

首次发布 (实际的)

2019年2月22日

研究记录更新

最后更新发布 (实际的)

2019年2月28日

上次提交的符合 QC 标准的更新

2019年2月26日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

3
订阅