All studies
CompletedNot ApplicableObservational

Examining the impacts of pathologists using the assistance of computer technology (artificial intelligence software) on the diagnosis of prostate cancer biopsies

When doctors check for prostate cancer, they take tiny tissue samples called biopsies. Specialist doctors, called pathologists, examine these samples under a microscope to find cancer cells. In the UK, pathologists face high workloads and rising numbers of tests. This study, led by the University of Oxford, looks at whether an approved artificial intelligence (AI) computer programme called Paige Prostate can help. The software scans digital images of the biopsy tissue and highlights areas that look suspicious. It also estimates the size and grade of any tumour. Pathologists review these computer findings before making their final diagnosis. The AI does not replace the human doctor; it acts as a helpful second pair of eyes. Researchers want to see if this technology speeds up results, improves accuracy, and helps the NHS manage resources more effectively.

At a glance

Status
Completed
Phase
Not Applicable
Sponsor
University of Oxford
Enrolment target
1,500
Start
28 Apr 2022
Estimated completion
29 Feb 2024

What is this study about?

Prostate cancer is the most common cancer in men in the UK. To confirm whether someone has prostate cancer, doctors take tiny samples of tissue from the prostate gland. These are called biopsies. Specialist laboratory doctors, known as histopathologists, look at these samples under a microscope to spot any cancer, see how aggressive it might be, and measure how much there is. This information helps doctors choose the best treatment.

In recent years, the number of biopsy tests has grown quickly, while the UK faces a shortage of specialist pathologists. To help support doctors, researchers are testing an artificial intelligence (AI) software tool called Paige Prostate. This tool analyses digital pictures of the tissue slices. It flags suspicious cells, measures potential tumours, and gives doctors extra visual information to review.

The main goal of this study is to see if using AI helps doctors make faster and more consistent decisions. Importantly, the computer programme never replaces the doctor. Human pathologists always make the final diagnosis. By testing this system in real NHS hospitals, the study aims to create clear safety rules for using AI in healthcare, helping patients get high-quality care without unnecessary delays.

Key takeaways

  • Tests an approved AI tool called Paige Prostate to assist NHS doctors reviewing prostate biopsies.
  • Specialist human pathologists remain in full control and make all final medical decisions.
  • Involves no extra hospital visits, needle tests, or changes to routine biopsy procedures.
  • Aims to make prostate cancer diagnoses faster, more consistent, and more accurate.
  • Led by the University of Oxford across three NHS hospitals in England.

Who may be eligible?

This study is open to men who are already having a routine prostate biopsy to check for suspected prostate cancer at one of the participating NHS hospitals in England.

You do not need to apply for a special procedure. If your hospital is taking part, your biopsy sample will naturally be suitable for the study as part of your normal testing pathway.

You cannot take part if you have chosen to opt out of clinical research through standard NHS consent policies, or if the tissue sample being tested is not from the prostate gland.

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.

  1. I am a male patient having a prostate biopsy.
  2. My biopsy is taking place at a participating NHS hospital in England.
  3. I am having the biopsy because doctors suspect prostate cancer.
  4. I have not opted out of standard NHS research or clinical data sharing.
Answer every question to see your result.

What does participation involve?

Taking part in this study does not require any extra hospital visits, blood tests, or medications. You will simply follow your normal NHS care pathway for a prostate biopsy. Once your doctor takes the tissue sample, the laboratory will create digital scans of the slides. The specialist pathologist will examine them, assisted by the Paige Prostate AI tool, before confirming your diagnosis. Because this research happens quietly behind the scenes in the hospital lab, it will not interrupt your everyday life or delay your treatment decisions. The overall study runs until early 2024.

Potential risks and benefits

There are no known extra physical risks from taking part, as you receive the exact same standard medical procedures as any other patient. The AI software is safely regulated, and human doctors check all results and make all final medical decisions. A potential benefit is that having an extra digital check might help ensure your biopsy results are as detailed and accurate as possible. You also help improve how the NHS diagnoses prostate cancer in the future. If you do not wish for your samples to be used in this research, you have the right to opt out at any time without your regular NHS care being affected in any way.

Locations (3)

  • John Radcliffe Hospital
    Approximate
    Oxford, England
  • University Hospital Coventry
    Approximate
    Coventry, England
  • Southmead Hospital
    Approximate
    Bristol, England

Common questions

Is artificial intelligence replacing my human doctor?

No. A specialist human doctor always reviews your results and makes the final diagnosis. The AI simply acts as an assistant to highlight areas of interest.

Will I need to undergo extra tests or give more tissue?

No. The study uses the routine biopsy samples already taken by your medical team. You do not need any additional appointments or procedures.

Will using AI delay my test results?

No. The AI software is designed to help pathologists work more smoothly. It is not expected to delay your results or your care.

How is my personal information protected?

All research within the NHS follows strict data privacy rules. Your digital samples and details are kept secure and confidential.

What happens if the AI and the doctor disagree?

If the AI flags something unexpected, the doctor will run extra checks and review the sample again with colleagues before approving the final result.

How to find out more

Monica Dolton

Always speak to your GP or specialist before deciding to take part in a study.

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