Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Donation | Other | — | UNRESOLVED |
| Healthcare data linkage | Other | — | UNRESOLVED |
| Tissue donation | Other | — | UNRESOLVED |
| Urine Donation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort Observation
- description
- 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.
- interventionNames
- Other: Tissue donation
- Other: Blood Donation
- Other: Urine Donation
- Other: Healthcare data linkage
Primary outcomes (3)
- measure
- Presence of clinically significant prostate cancer confirmed on biopsy, defined as any Gleason pattern 7 or greater
- timeFrame
- 6 weeks
- description
- Proportion of men with significant prostate cancer categorised as gleason pattern 7 or greater
- measure
- Time to metastases in men with prostate cancer
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
References
Publications (1)
- DERIVEDMarsden 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 34218972