ReIMAGINE Prostate Cancer Risk

March 21, 2023 updated by: University College, London

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, United Kingdom, NW1 2PG
        • University College London Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men who have been referred to secondary care with a suspicion of prostate cancer

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Tissue donation
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.
Other: Blood Donation
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.
Other: Urine Donation
Urine will be collected prior to prostate biopsy
Other: Healthcare data linkage
Men will consent to healthcare data linkage via national databases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of clinically significant prostate cancer confirmed on biopsy, defined as any Gleason pattern 7 or greater
Time Frame: 6 weeks
Proportion of men with significant prostate cancer categorised as gleason pattern 7 or greater
6 weeks
Time to metastases in men with prostate cancer
Time Frame: 3 years
Development of secondary cancers or cancer recurrence
3 years
Time to prostate cancer related death
Time Frame: 3 years
Time to prostate cancer related death in men diagnosed with prostate cancer
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to new prostate cancer in men without cancer at baseline
Time Frame: 3 years
Presence of newly diagnosed prostate cancer in men who were cancer free at baseline
3 years
Time to cancer progression in men identified with prostate cancer at baseline
Time Frame: 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
Time Frame: 3 years
Time to prostate cancer specific death in all men
3 years
Time to all-cause death in all men
Time Frame: 3 years
Time to all-cause death in all men
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

King's College London
Imperial College London
Medical Research Council
Cancer Research UK

Investigators

  • Principal Investigator: Hashim U Ahmed, FRCS, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2019

Primary Completion (Anticipated)

May 31, 2025

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123973

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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