PRIME Trial
Our study assesses if bi-parametric MRI can provide similar information to multi-parametric MRI in diagnosing clinically significant prostate cancer.
ClinicalTrials.gov Identifier: NCT04571840
Current trial status: Recruiting
Background
The standard way of diagnosing prostate cancer is to carry out a multiparametric MRI scan and targeted biopsy. This type of scan normally involves the insertion of a cannula in one of your veins, through which contrast is given.
Another type of MRI scan (biparametric) can be performed that does not require contrast, and therefore does not require the insertion of a cannula. We currently do not know for certain whether using this type of MRI will allow us to detect the same, more or less prostate cancer than if we use the standard (multiparametric) type of MRI. Current evidence supports the idea that using biparametric MRI may detect a similar amount of cancer to when it is not used but one advantage is it may allow a man to have a scan without contrast. Because the use of contrast comes with a risk of allergy and potential side effects, this would be an improvement over the standard (multiparametric) MRI if the scan was just as good in identifying suspicious parts of the prostate.
The main purpose of this study is to assess if biparametric MRI can provide similar information to multiparametric MRI. You will undergo a multiparametric MRI, which is the currently used method of investigating the prostate for cancer. The doctor reviewing your scan will be asked to review the MRI scan in a different order than they usually are to investigate whether biparametric MRI can offer the same degree of accuracy of detecting prostate cancer as multiparametric MRI.
Award-winners
PRIME team win at European Association of Urology
The UCL Division of Surgery PRIME team has won first prize at the European Association of Urology 2023 in Milan.
3 April 2023
Are you a patient?
The PRIME study will begin recruiting from hospitals around the UK and globally in Q1 2022. To participate, your GP must have referred you to hospital for further investigations for prostate cancer, such as an MRI scan. You may be approached to participate in the study if you meet the criteria. This is only applicable to sites that are taking part in the PRIME study. Provisionally, in the UK, these include UCLH, Royal Free, Whittington, and Addenbrooke's. You can follow the progress of the trial and see which hospitals are recruiting for the study by checking this website regularly.
Use of data
We are grateful for participation in the PRIME trial. Here is some information on how data is managed.
University College London (UCL)
PRIME is a clinical trial focused on enhancing the diagnostic accuracy of prostate cancer by comparing biparametric and multiparametric MRI techniques.
Your anonymised personal data will be shared with the following partners for research purposes:
- Cerebriu, Denmark: A company specialising in the development of AI solutions for medical imaging, aiming to improve diagnostic accuracy and efficiency. Data will be used to develop an AI algorithm to determine the value of contrast (DCE) sequences for prostate cancer diagnosis.
- Lucida Medical, UK: A medical technology company focused on developing AI-powered imaging solutions for early cancer detection and diagnosis. Data will be used to develop an AI algorithm to further prostate cancer diagnosis.
- Charité – Universitätsmedizin Berlin, Germany: A renowned university hospital in Berlin with a strong focus on research and innovation in healthcare. Data will be used to develop an AI algorithm to determine the value of contrast (DCE) sequences for prostate cancer diagnosis.
- MIM Software Inc, USA: A leading provider of advanced medical imaging software solutions for radiology, radiation oncology, and nuclear medicine. Data will be used as part of the reporting workflow as part of the trial.
- ARIA Matrix, India: A software company that provides image analysis and management solutions for preclinical toxicology and pathology applications. Data will be used to develop an AI algorithm to further prostate cancer diagnosis.
Your anonymised personal data will be retained by these partners for a period of 24 months after the trial has completed.
Are you an investigator?
With over 60 centres expressing interest and 30 going through the contract process, we are not currently taking on further sites. We hope to collaborate with you on future studies. For more information, please contact ncita.prime@ucl.ac.uk or primestudy@ucl.ac.uk.
University College London NCITA Trials group
Chief Investigator: Prof Veeru Kasivisvanathan
- Professor Caroline Moore
- Dr Pramit Khetrapal
- Dr Chris Brew-Graves
- Professor Shonit Punwani
- Mr Alexander Ng
- Miss Aqua Asif
- Mr Vinson Wai-Shun Chan
- Mr Arjun Nathan
- Miss Marimo Rossiter.
Key collaborators
- Statistics by: University of Birmingham Test Evaluation Research Group, Dr Yemisi Takwoingi, Professor Jon Deeks.
- EAU Research Foundation: Dr Wim Witjes, Ms Christien Caris, Professor Anders Bjartell.
- Trial Network: PRECISION & START Consortium.
Sponsor
- University College London (UCL)
Supported by
- Cancer Research UK
- The National Institute for Health Research
Funded by
- EAU Research Foundation
- The John Black Charitable Foundation
- Prostate Cancer UK
- The Dieckmann Foundation
World experts in prostate cancer, part of the START consortium who are part of the group delivering the PRIME study.
