ReIMAGINE Prostate Cancer Risk
Research type
Research Study
Full title
A prospective cohort study in men with a suspicion of prostate cancer who are referred onto an MRI-based diagnostic pathway with donation of tissue, blood and urine for biomarker analyses
IRAS ID
251166
Contact name
Hashim Ahmed
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/05/171 , UCL data protection registration number
Duration of Study in the UK
4 years, 9 months, 31 days
Research summary
The manner in which men at risk of prostate cancer are managed has undergone considerable change over the last decade. These changes have been largely driven by the uptake of multi-parametric MRI (mpMRI) prior to prostate biopsy, which high quality studies have shown result in: fewer men biopsied overall; fewer needle deployments; less over-diagnosis; fewer missed clinically important cancers; and less overall harm to the patients
This new level of precision creates problems however as all the risk models currently in use for prostate cancer risk estimation are based on data derived from a TRUS biopsy pathway (a biopsy performed via the back passage without knowledge as to whether a man had cancer or not, and if there was a cancer, blind to its location).
As there is no obvious method to adjust for this error the general view is that new and better risk-stratification and prediction models will need to be created using inputs that are derived from men undergoing a contemporary assessment (i.e. mpMRI prior to biopsy).
ReIMAGINE Prostate Cancer Risk will recruit men referred to secondary care who have been clinically advised to have a prostate biopsy. Consented men will be asked to donate blood, urine, prostate tissue (taken at the time of their biopsy) and access to the clinical data and imaging data from their standard of care diagnostics. These biological samples and pseudonymised clinical data will be shared with both commercial and academic partners who have developed biomarkers to assist in making the risk stratification of these men more precise.
No further study visits are required however all men will be tracked until death via linkage with national databases allowing the opportunity for greater understanding and prediction of down-stream key events such as clinical progression (cancer recurrence), time to metastases (development of secondary cancers) and death.REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/1128
Date of REC Opinion
7 Aug 2019
REC opinion
Further Information Favourable Opinion