NCT04060589

ReIMAGINE Prostate Cancer Risk

Status unknown Last updated 22 March 2023

What this trial tests

trial testing Tissue donation in Prostate Cancer in 1,000 participants. Status unknown.

Timeline

3 September 2019

Primary endpoint
31 May 2025

31 May 2025

Quick facts

Lead sponsor	University College, London
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	3 September 2019
Primary completion	31 May 2025
Estimated completion	31 May 2025
Sites	3 locations across United Kingdom

Drugs / interventions tested

• Tissue donation
• Blood Donation
• Urine Donation
• Healthcare data linkage

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University College, London

Who can join

Adults 18 to 90, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The BARCODE1 Pilot: a feasibility study of using germline single nucleotide polymorphisms to target prostate cancer screening.
   Benafif S, Ni Raghallaigh H, McGrowder E, Saunders EJ, et al · · 2022 · cited 29× · PMID 34214236 · DOI 10.1111/bju.15535
2. The ReIMAGINE Multimodal Warehouse: Using Artificial Intelligence for Accurate Risk Stratification of Prostate Cancer.
   Santaolalla A, Hulsen T, Davis J, Ahmed HU, et al · · 2021 · cited 5× · PMID 34870187 · DOI 10.3389/frai.2021.769582
3. The ReIMAGINE prostate cancer risk study protocol: 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.
   Marsden T, McCartan N, Brown L, Rodriguez-Justo M, et al · · 2022 · cited 4× · PMID 35202397 · DOI 10.1371/journal.pone.0259672
4. 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 analyse
   Marsden T, Ahmed HU, Emberton M, ReIMAGINE Study Group. · · 2021 · cited 3× · PMID 34218972 · DOI 10.1016/j.eururo.2021.06.011
5. The RECONCILE study protocol: Exploiting image-based risk stratification in early prostate cancer to discriminate progressors from non-progressors (RECONCILE).
   Marsden T, Attard G, Punwani S, Giganti F, et al · · 2024 · cited 1× · PMID 39418289 · DOI 10.1371/journal.pone.0295994