The Vanguard Path Study
Study Aims
Members of the Vanguard Path Study team (from left to right): Philip Charlton, Andrew Protheroe, Clare Verrill, Richard Bryant, and Jonathan Aning.
How we will use Artera's MMAI in the Vanguard Path Study
As we have already explained (see Background) determining a Gleason grade, and then deciding how aggressive a man’s prostate cancer might be, or how likely it is to spread beyond the prostate is a complex and sometimes difficult task.
We believe that the Artera MMAI programme, called the 'ArteraAI Prostate Test' can more accurately predict how likely a man’s cancer is to spread, and which treatment is likely to benefit him the most. In the Vanguard Path Study, our aim is to evaluate the AI tool to see if this is the case - improving the precision of diagnosis using AI could lead to better outcomes for men, helping to identify the optimal treatment and reducing the likelihood of debilitating side effects from unnecessary treatments.
Importantly, in the study we will provide crucial evidence on its potential value for men treated in NHS hospitals, rather than in the USA where the test is currently used.
We will test the accuracy of the AI in three NHS hospitals – in Oxford, Bristol and Glasgow – which are among the leading centres for digital pathology in the UK. We need to check whether the AI is compatible with the hospitals’ current technology, ensuring it can be integrated into NHS systems without causing delays or disrupting existing processes. We will also work on standardising the data and systems to ensure a 'level playing field' within the study. This is Work Package 1.
We will test the MMAI tool with biopsies and clinical data both in retrospective cohorts of patient tissue (Work Package 2) and in tissue from men who present in NHS clinics held within the three hospitals. This is called a Service Evaluation (Work Package 3). At this stage, we want to understand how the MMAI tool might influence the decisions the clinicians make on men’s treatment and understand how it might be used in the NHS setting but without it affecting patients yet.
Another area we will focus on is patient and public involvement and engagement (PPIE) with the study, and we have already embedded public and patient opinions in the work we have done to date, including in the grant application and design of the study. We have four men with lived experience of prostate cancer embedded in our team, who are on the study Project Management Board. We aim to understand how much information patients with a diagnosis of prostate cancer may wish to receive about the outputs of the MMAI, and we will create public facing material for social media etc to publicise the study and outcomes and ensure acceptability of the technology.
We also have an element of qualitative research within the study, where we will explore the acceptability and feasibility of the Artera MMAI test for both patients and clinicians and an education element, with the creation of materials to help the future generation of pathologists to understand this AI and its' consequences on practice (Work Package 4).
Finally, prostate cancers can look very different under the microscope, and these differences may reflect important genetic changes that drive the disease. In Work Package 5, we will investigate how the appearance of prostate cancer relates to its underlying biology using advanced artificial intelligence (AI) and genetic analysis.
We will analyse biopsy samples from patients with intermediate-risk prostate cancer. AI tools will identify different patterns of cancer growth and highlight areas that appear unusual or complex. We will then perform detailed molecular analyses on these specific regions to better understand the changes occurring within the tumour. Unlike conventional approaches that analyse an entire tissue sample as a whole, our method allows us to study small areas of tissue individually. We will also examine the surrounding tissue to better understand how neighbouring cells may influence cancer behaviour. This will provide a more detailed picture of how prostate cancers develop and evolve, including differences that may exist within the same tumour.
Overall, Work Package 5 aims to improve our understanding of prostate cancer biology and identify new ways to predict which cancers are most likely to become aggressive, ultimately supporting more personalised treatment decisions for patients.