PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Number of men who could avoid repeat biopsy as determined by the Negative predictive value and specificity of mp-MRI for Clinically significant disease.
研究概览
简要总结
The incidence of prostate cancer is rising however the number of deaths from prostate cancer is stable. Meaning the investigators are diagnosing many men with prostate cancer that will not impact on their life. The rise in incidence is mainly due to increased use of the blood test Prostate Specific Antigen (PSA), as a screening test.
Currently men suspected of having prostate cancer, identified by a raised PSA undergo trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as it is random and performed blind-the operator does not know where the cancer is. Thus many low-risk cancers that do not need treating are diagnosed and many high risk cancers are missed or incorrectly classified. So, men with a negative biopsy or those with low risk disease are usually advised to undergo another TRUS biopsy.
An imaging test is needed that could help men and their doctors decide whether the biopsy is a true reflection of what is inside his prostate.
The investigators will test the role of two imaging tests. The first, multi-parametric magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the results of these tests with a detailed biopsy map-transperineal template prostate mapping biopsy (which is currently the best way to find out what is in the prostate but requires multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one or more TRUS biopsies and who have been advised to have further tests on as part of standard of care. They will be recruited from UCLH referral letters and clinics.
The investigators aim is to see if either of these tests can confidently rule out the presence of clinically important disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men who have undergone prior trans-rectal biopsies.
- •Men undergoing further evaluation of their prostate and who are seeking characterisation using Transperineal Template Prostate Mapping Biopsy.
排除标准
- •Previous history of prostate cancer treatment
- •Men unable to have MRI scan, or in whom artefact would reduce quality of MRI.
- •Men unable to have general or regional anaesthesia
- •Men unable to give informed consent
结局指标
主要结局
Number of men who could avoid repeat biopsy as determined by the Negative predictive value and specificity of mp-MRI for Clinically significant disease.
时间窗: 18 months
Performance characteristics of mp-MRI for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity
Number of men who could avoid repeat biopsy as determined by the negative predictive value and specificity of Prostate HistoScanning for Clinically significant disease.
时间窗: 18 months
Performance characteristics of Prostate HistoScanning for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity
次要结局
- Proportion of men correctly identified as having no cancer on Imaging (mp-MRI and Prostate HistoScanning)(18 months)
- Number of men correctly identified by Imaging (mp-MRI and Prostate HistoScanning) to have CLINICALLY SIGNIFICANT disease(18 months)
- Test- retest reproducibility of Prostate HistoScanning™.(18 months)
- Proportion of patients with correct disease risk stratification using MRI/US guided biopsies as determined by sensitivity and specificity(18 months)
- Number of patients with bothersome Lower Urinary tract symptoms following Transperineal Template Mapping biopsy(18 months)
- Number of patients with worsened erectile function compared to baseline following Transperineal Template Mapping biopsy(18 months)
研究者
Professor Mark Emberton
Professor of Interventional Oncology
University College London Hospitals