Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04060589 |
| Other study ID # |
123973 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 3, 2019 |
| Est. completion date |
May 31, 2025 |
Study information
| Verified date |
March 2023 |
| Source |
University College, London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
ReIMAGINE Prostate Cancer Risk is a multi-centre, prospective, observational, longitudinal
cohort study of men referred to secondary care with a suspicion of prostate cancer. The aim
of the study is to develop a robust baseline risk stratification system for men at risk of
prostate cancer.
Men whose serum Prostate Specific Antigen (PSA) level is 20ng/ml or less, whose
multi-parametric magnetic resonance imaging (mpMRI) scan has been scored as Prostate Imaging
Reporting and Data System (PIRADS)/LIKERT score 3, 4 or 5, and who have been advised and
accepted the need for a targeted and systematic prostate biopsy will be invited to take part
in the study and be asked to donate blood, urine, imaging files and prostate biopsy for
biomarker analysis.
Description:
ReIMAGINE Prostate Cancer Risk is a multi-centre, prospective, observational, longitudinal
cohort study of men referred to secondary care with a suspicion of prostate cancer or men who
are undergoing further tests for prostate cancer staging assessment. Men with a serum PSA
level of 20ng/ml or less, whose mpMRI scan has been scored as PIRADS/LIKERT score 3, 4 or 5,
and who have been advised and accepted the need for a targeted and systematic prostate biopsy
will be invited to enrol.
Men will be recruited across a number of high-volume National Health Service (NHS) centres
which already have an mpMRI based diagnostic pathway. All eligible patients referred to
secondary care with a suspicion on prostate cancer will be considered for screening.
Potential participants will be identified at the point of referral or routine urology cancer
clinics. Patients will be approached by the ReIMAGINE study team and consented. The initial
discussion may be over the telephone Once the consent form is signed, patients will be asked
to donate blood, urine and three additional samples of prostate tissue (taken at the time of
their biopsy) for biomarker and Deoxyribonucleic acid (DNA) analysis.
Imaging files from the MRI scan will also be collected and stored on the study data
warehouse. Small sections of tissue will be cut from the standard of care blocks (post NHS
reporting) and then returned back to the hospital.
After collection of the cross-sectional biological samples within ReIMAGINE, men will revert
to NHS standard of care, attending a routine outpatient appointment to obtain the results
from their biopsy. We will collect healthcare information on study participants during the
study and three years after their prostate biopsy. Further funding will be explored for
life-long collection of this data.
The ReIMAGINE team aim to recruit 1,000 men with a PIRADs/LIKERT score 3, 4 or 5 who are
undergoing an MRI-directed prostate biopsy. Of these 1,000 biopsies, we anticipate that 60%
will have any cancer detected on histology (3+3 or greater) giving approximately 400 cases of
clinically significant cancer (Gleason 7 or more).
