Evaluation of the Performance of the Glycoscore Biomarkers for the Detection of Clinically Significant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- An evaluation of the diagnostic performance of the GlycoScore biomarkers for the detection of clinically significant prostate cancer (Gleason score of ≥7).
研究概览
简要总结
GlycoScore Dx Limited, a diagnostics company based in the United Kingdom have identified three glycoproteins, that showed promise as biomarkers of prostate cancer in initial validation studies. The purpose of this study is to further evaluate the sensitivity and specificity of the GlycoScore biomarkers for the detection of clinically significant prostate cancer. Sensitivity and specificity will be determined for each marker, combinations of the three markers and combinations of the GlycoScore biomarkers with PSA (prostate specific antigen). The results from this study will be used to identify the most suitable biomarker/biomarkers for use in developing a GlycoScore test.
This is a prospective, non-interventional study using venous blood samples taken from patients with suspected prostate cancer or on active surveillance, attending the hospital Urology department for a transperineal biopsy.
详细描述
Worldwide, prostate cancer is the most commonly diagnosed cancer in men and the fifth leading cause of cancer death in men. This amounted to 1,414,249 newly diagnosed cases and 375,000 deaths worldwide yearly from this disease in 2020. Globally, prostate cancer is the most commonly diagnosed cancer in more than fifty percent of countries (112 of 185). It presents a significant clinical burden in terms of volume and as a diagnostic challenge.
The initial diagnosis of prostate cancer relies on the detection of PSA (prostate specific antigen) in patient blood. While PSA is relatively good at identifying prostate cancer, PSA levels can be elevated for reasons other than cancer (giving a false positive result). Two thirds of men with a raised PSA level don't have prostate cancer meaning that many men undergo unnecessary & invasive follow up procedures, such as tissue biopsy. Prostate biopsies place a huge burden on both healthcare systems, and individuals with suspected prostate cancer. They are painful, can lead to complications, infections and in extreme circumstances, death.
Therefore, the poor specificity of the PSA test, combined with the disparate natural histories of many prostate cancers has limited its utility as a screening tool.
A combination of clinical and pathological features, such as the tumour grade (Gleason score or Gleason Grade Group), combined with clinical examination (digital rectal examination), MRI (magnetic resonance imaging) and isotope bone scan are commonly used to determine the aggressiveness and curability of tumours with radical treatment. PSA measurement is used as part of this assessment but, as other factors can influence PSA levels, it cannot be used to assess risk or guide treatment in isolation.
There remains an unmet clinical need for a better screening and diagnostic test for prostate cancer. Such a test must also be able to differentiate between early, low-risk cancers that do not require radical treatment and more aggressive tumours where radical treatment is preferable. By identifying which patients have a clinically significant risk of prostate cancer we believe our test could provide a solution to both.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 18 years and over
- •The patient is being investigated for suspected prostate cancer or is on active surveillance
- •The patient is able to give consent to take part in the study
排除标准
- •A patient who has already taken part in the study
- •A patient with an active urinary tract infection
- •The patient has a prior diagnosis of any other cancer or is receiving any cancer treatment (including ADT)
- •The patient is currently or within the last 4 months enrolled on another study involving an investigational medicinal product
结局指标
主要结局
An evaluation of the diagnostic performance of the GlycoScore biomarkers for the detection of clinically significant prostate cancer (Gleason score of ≥7).
时间窗: Pre-biopsy (one time point)
A comparison of calculated sensitivity, specificity and positive and negative predictive values for clinically significant prostate cancer for the following: Each biomarker, alone and in combination with PSA (measured on from the same blood sample using a CE-marked assay) Each possible combination of GlycoScore biomarkers, alone and in combination with PSA The reference method for diagnosis of prostate cancer will be biopsy, and the reference method for identifying patients who do not have cancer will be by a combination of mpMRI and/or biopsy.
次要结局
- A comparison of the diagnostic performance of the GlycoScore biomarkers (with and without PSA) against the performance of the hospital PSA test alone for the detection of clinically significant prostate cancer (Gleason score of ≥7).(Pre-biopsy (one time point))
- An evaluation of the ability of the calculated 'GlycoScore' to distinguish between individual Gleason scores and grade groups(Pre-biopsy (one time point))
- Establishment of a 'GlycoScore' algorithm(Pre-biopsy (one time point))
- An evaluation of the ability of the calculated 'GlycoScore' to distinguish between CPG groups 1 to 5 (Cambridge Prognostic Group classification)(Pre-biopsy (one time point))