Active not recruitingOBSERVATIONAL

Imperial Prostate 6 - Cancer Histology Artificial Intelligence Reliability Study.

This study, called Imperial Prostate 6, is investigating a new artificial intelligence (AI) tool, Galen Prostate AI, to see if it can accurately identify prostate cancer in tissue samples. Currently, many men in the UK undergo prostate biopsies, and the number of samples pathologists need to review is growing. There's also a shortage of pathology staff. This AI system could potentially help by quickly sifting through a large number of samples, highlighting suspicious areas, and making the diagnosis process more efficient and consistent. The study will assess if this technology is accurate enough and offers good value for money to be used within the NHS to help doctors manage the increasing workload.

At a glance

Status

Active not recruiting

Sponsor

Imperial College London

Enrolment target

750

Start

11 Mar 2022

Estimated completion

30 Apr 2025

Prostatic Neoplasms

What is this study about?

Imagine your doctor needs to check a small piece of your prostate tissue (a biopsy) for signs of cancer. Usually, a specialist doctor called a pathologist carefully examines this tissue under a microscope. With more and more men getting tested for prostate cancer in the UK, the number of these tissue samples has grown significantly, and it’s a lot for pathologists to review. Sometimes, even highly skilled pathologists might have slightly different opinions on what they see, which can affect treatment decisions.

This study is looking at a new computer system that uses Artificial Intelligence (AI), called Galen Prostate AI. Think of it as a very advanced assistant for pathologists. This AI has been trained with a huge number of prostate tissue samples to recognise different cell types and patterns, and to help identify if cancer is present. The goal is to see if this AI system can accurately and reliably help pathologists go through the tissue samples, potentially making the process faster and more consistent. If it works well, it could help the NHS manage the increasing workload and ensure men get accurate diagnoses efficiently.

This research is important because it could lead to better and quicker diagnoses for men with prostate cancer. It could also help address the shortage of pathology staff in the NHS by giving them a powerful tool to assist their work, allowing them to focus on the most complex cases. The study wants to determine if this AI is not only accurate but also provides good value, meaning it could be a real benefit to patients and the healthcare system.

Key takeaways

A new AI system (Galen Prostate AI) is being tested to diagnose prostate cancer.
The study aims to see if AI can help pathologists manage increasing workload and improve speed/consistency of diagnosis.
Participation involves analysis of existing biopsy and imaging results, no direct patient intervention.
No direct risks to participants as personal details are removed from data.
This research could lead to better and quicker prostate cancer diagnosis for future patients in the NHS.

Who may be eligible?

To join this study, you would need to be a man (registered as either cisgender male or transgender female who has not taken any hormones before) and be 18 years old or older. You would also need to be scheduled for a prostate biopsy because of a high PSA blood test result or an unusual finding during a rectal exam, and have had a special type of MRI scan beforehand, which led to the recommendation for a biopsy.

The study also includes a separate part for calibration, which may involve using tissue samples from patients who have already had a biopsy within the last year. This means some of the data will come from previous biopsies, rather than new ones.

You would not be able to join if you are unwilling or unable to give your consent to participate. Also, if you have received certain treatments for prostate cancer in the six months before the study, such as hormone therapy, radiotherapy, or other procedures that changed the prostate tissue structure, you would not be eligible. However, treatment for prostate enlargement (which is not cancer) is generally allowed.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man (cis or trans, no prior hormones)?
Are you 18 years old or over?
Are you scheduled for a prostate biopsy due to high PSA or abnormal exam?
Have you had a pre-biopsy MRI scan?
Have you avoided certain prostate cancer treatments (like hormone therapy, radiotherapy) in the last 6 months?

Answer every question to see your result.

What does participation involve?

This study is primarily looking at tissue samples and images rather than directly involving you in new procedures. If you meet the inclusion criteria, it means your existing biopsy results and imaging might be used and analysed by the AI system. You would not need to attend extra visits or undergo additional medical assessments, nor would you receive any new medication as part of this specific study. Your participation would mainly involve allowing your de-identified medical data (your biopsy slides and scan results, with your personal details removed) to be reviewed by the Galen Prostate AI system. The total duration of your individual participation in terms of data contribution would be limited to the analysis of your existing samples.

Potential risks and benefits

Since this study primarily involves the analysis of existing, de-identified medical information, there are no direct physical risks to you from participating. Your involvement helps researchers evaluate new technology that could improve prostate cancer diagnosis for future patients. While there may be no direct benefit to you personally, your contribution is valuable to advancing medical care. Remember, you would always have the right to withdraw your consent for your data to be used at any point, without affecting your medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Coventry and Warwickshire Nhs Trust
Verified postcode
Coventry, United Kingdom
Chelsea and Westminster Hospital Nhs Foundation Trust - Chelsea
Verified postcode
London, United Kingdom
Chelsea and Westminster Hospital Nhs Foundation Trust - West Middlesex
Verified postcode
London, United Kingdom
Imperial College Healthcare Nhs Trust
Verified postcode
London, United Kingdom
University College London Hospitals Nhs Foundation Trust
Verified postcode
London, United Kingdom
University Hospital Southampton Nhs Foundation Trust
Verified postcode
Southampton, United Kingdom

Common questions

What is AI and how does it help with cancer diagnosis?

AI, or Artificial Intelligence, is a computer system that can learn to recognise patterns. In this study, it's being taught to look at prostate tissue samples and identify signs of cancer, helping specialist doctors with their diagnosis.

Will this study change my current treatment plan?

No, this study is about evaluating a new AI system for diagnosis. It will not affect your current treatment or care plan. Your doctors will continue to make decisions based on standard practices.

Who will see my personal information?

Your personal details will be kept confidential. The study will use your medical information (like biopsy slides) without identifying you, ensuring your privacy is protected.

Why is this study important for the NHS?

The NHS faces a growing number of prostate cancer tests and a shortage of specialist staff. This study aims to find out if AI can help manage this workload, making diagnoses quicker and more consistent for everyone.

Do I need to do anything extra if I participate?

No, if you're eligible, your participation will involve the analysis of your existing biopsy and imaging results. You won't need to attend extra appointments or take any new medications for this study.