Prolaris Enhanced Risk Stratification - an ecONomic and clinicAL Evaluation (PERSONAL)
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
条件
研究类型
注册 (预期的)
联系人和位置
学习地点
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West Yorkshire
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Leeds、West Yorkshire、英国、LS9 7TF
- 招聘中
- St James's University Hospitals NHS Trust
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接触:
- William Cross, MRCS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
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
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Results of the test received.
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30-60mins
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Treatment counselling
大体时间:30-60mins
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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.
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30-60mins
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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