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About Me.

PROMIS OVERVIEW

PROMIS was a one-of-a-kind study conducted at UCL between 2012 and 2015. This study was the first to prove that MRI is a superior test for prostate cancer detection compared to standard transrectal biopsy.

 

In total, 576 participants with raised PSA underwent MRI in multiple UK institutions, followed by combined transrectal-transperineal template mapping (TPM) biopsies at 5 mm intervals, resulting in the most extensively characterised prostate cancer diagnosis cohort in existence. ​

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Further details on PROMIS (ISRCTN16082556; NCT01292291) can be found below (links to the UCL MRC Clinical Trials Unit and the original PROMIS Lancet 2017 paper).

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PROMIS DATASET

The Re-IMAGINE consortium, in collaboration with the National Cancer Imaging Translational Accelerator (NCITA), has made the PROMIS Study Dataset (clinical information, biopsy reports and MRI images) open and freely available to the scientific community for non-commercial, non-profit use. This is to facilitate future discovery in prostate cancer diagnosis and treatment. 

 

Further information on this effort can be found at the NCITA website (link below). 

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Researchers requiring the PROMIS Study Dataset must apply for access (https://ncita.org.uk/promis-data-set-open-access-request/). Applications are reviewed and approved by the Re-IMAGINE Consortium. 

PROMIS DIGITAL PATHOLOGY & CLINICAL OUTCOMES

PROJECT OVERVIEW

All PROMIS biopsies were interpreted by the study pathologists, recording essential details like cancer grade. While this is critical, modern image analysis unlocks new possibilities for examining prostate tissue with unprecedented precision using computer algorithms.

 

The Re-IMAGINE Consortium and its academic partners aim to enhance the PROMIS Study Dataset by:

   1.   Digitising PROMIS biopsy slides to establish a digital pathology repository.

   2.  Collecting linked hospital data on PROMIS patient outcomes, including prostate cancer mortality.

 

This initiative will create one of the most comprehensive prostate cancer datasets globally, combining MRI and pathology reports, clinical outcomes, and digital pathology images from a unique, unparalleled study—an invaluable resource for researchers worldwide.

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ETHICS & GOVERNANCE

The project received ethics approval in June 2024 from the Yorkshire & The Humber - Sheffield Research Ethics Committee (Ref: 24/YH/0106, sheffield.rec@hra.nhs.uk).

 

Since the original PROMIS study consent did not include slide digitisation and outcome retrieval from modern NHS systems, support under section 251 of the NHS Act 2006 has been given by the Health Research Authority following advice from the Confidentiality Advisory Group (Ref: 24/CAG/0105, cag@hra.nhs.uk). 

 

The data will be collected and anonymised by trained research team members, in full compliance with all information governance regulations. Participants in the National Data Opt-out will not be included. The generated information will be integrated into the PROMIS Study Dataset, governed by the Re-IMAGINE consortium and NCITA.

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This project is currently supported by CRUK (EDDAMC-2021\100011).

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PATIENT & PUBLIC INVOLVEMENT

To assess the study’s acceptability, including the absence of original consent for biopsy slide digitisation and outcome retrieval from modern NHS systems, the UCL group conducted patient and public involvement and engagement (PPIE) activities on three occasions: September 2023, July 2024, and December 2024.

 

In total, eight patients and representatives, including one from the original PROMIS study, participated. The sessions provided clear information about the proposed work and allowed patients to share feedback on the acceptability of waiving additional consent and raise any concerns.

 

Feedback was overwhelmingly positive. Patients strongly supported not seeking additional consent to digitise biopsy slides and integrate them with PROMIS data (including MRIs and clinical outcomes) from NHS records, provided that information governance protocols are followed and National Data Opt-Out participants are excluded.

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Representative quotes below:​

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- "I would hate the pain and suffering I've gone through to go to waste."

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- "Trying to get retrospective consent is probably completely a nonstarter"

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- "I would hate anyone to go through what I've gone through, so please keep up the good work."

 

- "Research that helps to discover early prostate cancer and helps everybody to extend their lives and be with their families is good for us."

 

- "You've reached minority groups, so well done."

 

- "I as a patient, wouldn't have any objection."

 

- "There's always a security concern about personal data at any trial like this. You know you have to have confidence in the fact that data is going to be looked after well."

 

- "Anything that can assist with [prognosis, life expectancy] then myself as a patient, I'll be for it."

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Furthermore, a questionnaire survey in the December 2024 session revealed 100% of participants considered this research "extremely important", and "strongly agreed" it should go ahead without additional, explicit patient consent, provided all necessary approvals are obtained and regulations are adhered to.

 

The research team has already obtained ethical approval and Confidentiality Advisory Group support, and will handle the data with the utmost care using measures such as anonymisation, staff information governance training and highly secure computer environments. 

FURTHER DETAILS & CONTACT INFO

This study is publicly registered (link below).

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The research team will be regularly publicising research results in major medical conferences, relevant UCL-UCLH websites and social media outlets. 

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Patients and the public are encouraged to be involved in the research effort and contact the team with any questions at:

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reimagine@ucl.ac.uk​

v.stavrinides@ucl.ac.uk​​​

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This study is being launched with funding of £4.1m from the Medical Research Council and £1m from Cancer Research UK, as part of the MRC's Stratified Medicine Initiative. 

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© 2018 ReIMAGINE

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