ReIMAGINE Prostate Cancer Risk
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 (ReIMAGINE Prostate Cancer Risk)
1 other identifier
observational
1,000
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2019
CompletedFirst Posted
Study publicly available on registry
August 19, 2019
CompletedStudy Start
First participant enrolled
September 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMarch 22, 2023
March 1, 2023
5.7 years
August 15, 2019
March 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Presence of clinically significant prostate cancer confirmed on biopsy, defined as any Gleason pattern 7 or greater
Proportion of men with significant prostate cancer categorised as gleason pattern 7 or greater
6 weeks
Time to metastases in men with prostate cancer
Development of secondary cancers or cancer recurrence
3 years
Time to prostate cancer related death
Time to prostate cancer related death in men diagnosed with prostate cancer
3 years
Secondary Outcomes (4)
Time to new prostate cancer in men without cancer at baseline
3 years
Time to cancer progression in men identified with prostate cancer at baseline
3 years
Time to prostate cancer specific death in all men
3 years
Time to all-cause death in all men
3 years
Study Arms (1)
Cohort Observation
This is a cohort study where participating men will be asked to donate blood, urine, tissue in addition to access to standard of care tissue and medical data (including imaging files). Men will also consent to longer term healthcare data linkage.
Interventions
Biopsies will be performed as part of standard of care, additional cores will be performed for research. Access to standard of care prostate biopsy tissue will also be requested after standard of care reporting is complete.
Phlebotomy will be performed prior to tissue collection following trust standard operating procedures or drawn when cannula already in situ in preparation for the prostate biopsy.
Men will consent to healthcare data linkage via national databases.
Eligibility Criteria
Men who have been referred to secondary care with a suspicion of prostate cancer
You may qualify if:
- Any man with PSA 20 or less (value recorded \<90 days before study entry)
- Men who have undergone a prostate MRI as a standard NHS diagnostic work-up
- MRI lesion conforming to Likert/PIRADS 3, 4 or 5
- Radiological stage T3b or less
- Clinical or radiological stage N0 and M0
- No anti-androgen exposure in the preceding 6 months (5-alpha reductase inhibitors permitted)
- No prior treatment for prostate cancer (chemical, biological, ablative, surgical, radiotherapy)
- Previous trans urethral resection of the prostate (TURP) is permitted
- Willing and able to provide written informed consent.
You may not qualify if:
- Men unable to donate tissue, blood or urine.
- Previous prostate cancer treatment
- Previous prostate biopsy \<12 months from date of the mpMRI scan used to assess study eligibility (scoring PIRADS/Likert 3, 4 or 5)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Medical Research Councilcollaborator
- Cancer Research UKcollaborator
- Imperial College Londoncollaborator
- King's College Londoncollaborator
Study Sites (3)
University College London Hospital
London, NW1 2PG, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Related Publications (1)
Marsden T, Ahmed HU, Emberton M; ReIMAGINE Study Group. An update from the ReIMAGINE Prostate Cancer Risk Study (NCT04060589): A prospective cohort study in men with a suspicion of prostate cancer who are referred onto a magnetic resonance imaging-based diagnostic pathway with donation of tissue, blood, and urine for biomarker analyses. Eur Urol. 2021 Oct;80(4):398-399. doi: 10.1016/j.eururo.2021.06.011. Epub 2021 Jul 1.
PMID: 34218972DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hashim U Ahmed, FRCS
Imperial College London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2019
First Posted
August 19, 2019
Study Start
September 3, 2019
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
March 22, 2023
Record last verified: 2023-03