r-STRAT-PRO: Risk STRATification of PROstate cancer patients using novel rapid Leukocyte ImmunoTest™ blood test

“前列腺癌是欧洲男性最常见的癌症，欧盟每年有超过34万例新发病例和7.1万例死亡。事实上，专家预测，欧盟多达八分之一的男性在其一生中将被诊断患有前列腺癌。近年来，在检测前列腺癌的发病方面取得了重大进展。特别是，来自血液检查的前列腺特异性抗原（PSA）已被发现是前列腺疾病的有用标志物;然而，许多研究表明，它经常导致“假阳性”，可能导致患者的担忧和焦虑。因此，需要新的工具来根据可能的疾病严重程度对患者进行快速分类，以监测疾病进展，并能够开发用于监测疾病进展和复发的家庭监测试剂盒。为了解决这一未满足的临床需求，Oxford MediStress（OMS）开发了用于快速评估中性粒细胞功能（免疫系统的一个关键方面）的白细胞免疫测试（LIT（tm））。快速、便携、手持的即时检测（POC）分析一个针刺的血液，并定量评估一个人的白色血细胞（他们所谓的“中性粒细胞”）在试管中与我们的专利化学品混合时对化学“刺激”的反应能力。这项测试最近在伦敦的一项涉及前列腺癌患者的临床试验中得到了成功的评估，看看十分钟的测试是否能找出哪些患者患有最严重的疾病。根据我们合作的癌症专家的说法，这些结果提供了信心，该测试有一天可以作为一种风险分层方法，并作为一种监测前列腺和其他癌症疾病进展的方法，包括乳腺癌。拟议的可行性研究的结果将增加我们对该测试如何用于前列腺癌风险分层和疾病监测的当前临床实践的理解，它是否可以用于前列腺癌监测的其他领域，以及其他癌症。最后，该项目将提高我们对公司成功所需的临床监管和制造策略的理解，同时使患者和医疗保健提供者受益。"

"Prostate cancer is the most common cancer in European males, with over 340,000 new cases and 71,000 deaths each year in the EU. Indeed, experts predict up to 1 in 8 men in the EU will be diagnosed with prostate cancer during their lifetime. Significant progress has been made in recent years in detecting the onset of prostate cancer. In particular, prostate-specific antigen (PSA) from blood tests has been found to be a useful marker of prostate disease; however, a number of studies have shown that it often results in ""false positives"" that can lead to worry and anxiety among patients. Therefore, a need exists for new tools to rapidly classify patients based on likely disease severity, to monitor disease progression and to enable the development of home monitoring kits for monitoring disease progression and recurrence.To address this unmet clinical need, Oxford MediStress (OMS) has developed the Leukocyte ImmunoTest(tm) (LIT(tm)) for rapidly assessing neutrophil function, a key aspect of the immune system. The rapid, portable, hand-held point-of-care (POC) test analyses a pinprick of blood and quantitatively evaluates how well an individual's white blood cells (their so-called ""neutrophils"") are capable of responding to chemical ""stimulation"" in a test tube when mixed with our patented chemicals. The test has been successfully evaluated recently in a clinical trial involving prostate cancer patients in London to see if the ten-minute test could pick out which patients had the most severe disease. According to our collaborating cancer experts, these results provide confidence the test could one day act as a risk stratification method and as a method to monitor disease progression in prostate and other cancers, including breast cancer.The outputs of the proposed feasibility study will increase our understanding of how the test can be used in current clinical practice for risk stratification and disease monitoring in prostate cancer and to see whether it could be used in other areas of prostate cancer monitoring, as well as in other cancers. Finally, the project will improve our understanding of the clinical-regulatory and manufacturing strategies that the Company will need to adopt to be successful and, at the same time, benefit the patient and healthcare-provider."