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PRIME Trial Information

A study comparing bi-parametric MRI to multi-parametric MRI in the diagnosis of clinically significant prostate cancer.

ClinicalTrials.gov Identifier: NCT04571840

Current trial status: Recruiting

Prime

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.

Frequently asked questions

If you have questions about the study, check our FAQ document for answers.

Members of the award-winning PRECISION team awarded the 2019 BMJ Research Paper of the Year for the PRECISION study.
Members of the award-winning PRECISION team awarded the 2019 BMJ Research Paper of the Year for the PRECISION study. The same team will be delivering the PRIME Study.

 

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.

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: Mr 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.

John Black Charitable Foundation Logo

PCR

dieckmann

Cancer Research UK Logo

National Institute for Health Research (NIHR) Logo