Prostate CancerNCT04060589
ReIMAGINE Prostate Cancer Risk
An observational study of Prostate Cancer, run by University College, London at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Tissue donation, Blood Donation and Urine Donation
- How many people
- 1,000 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 3 Sep 2019to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men who have been referred to secondary care with a suspicion of prostate cancer
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University College London Hospital
London, NW1 2PG
Royal Free Hospital
London, NW3 2QG
Charing Cross Hospital
London, W6 8RF
About this study
Official title: 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.
Read the 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).
- Conditions
- Prostate Cancer
- Being tested
- Tissue donation, Blood Donation, Urine Donation, Healthcare data linkage
- Keywords
- Prostate cancer, Magnetic resonance imaging-targeted biopsy, Biomarker, MRI-based diagnostic pathway, magnetic resonance imaging, targeted biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue donationOther
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.
Blood DonationOther
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.
Urine DonationOther
Urine will be collected prior to prostate biopsy
Healthcare data linkageOther
Men will consent to healthcare data linkage via national databases.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tissue donation; Other: Blood Donation; Other: Urine Donation; Other: Healthcare data linkage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Time to metastases in men with prostate cancer
Development of secondary cancers or cancer recurrence
Measured: 3 years
Time to prostate cancer related death
Time to prostate cancer related death in men diagnosed with prostate cancer
Measured: 3 years
Secondary outcomes (4)
Time to new prostate cancer in men without cancer at baseline
Presence of newly diagnosed prostate cancer in men who were cancer free at baseline
Measured: 3 years
Time to cancer progression in men identified with prostate cancer at baseline
Time to cancer progression in men identified with prostate cancer at baseline
Measured: 3 years
Time to prostate cancer specific death in all men
Time to prostate cancer specific death in all men
Measured: 3 years
Time to all-cause death in all men
Time to all-cause death in all men
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start3 Sep 2019
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Cancer Research UK, Imperial College London, King's College London
- Responsible party
- Sponsor
- Investigators
- Hashim U Ahmed, FRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060589
- Sponsor's protocol ID
- 123973
- Status last verified
- Mar 2023
- First submitted
- 15 Aug 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34218972
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04060589
- Acronym / sponsor ID
- 123973
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Magnetic resonance imaging-targeted biopsy, Biomarker, MRI-based diagnostic pathway, magnetic resonance imaging, targeted biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Cancer Research UK, Imperial College London, King's College London
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Observation | – | Other: Tissue donation, Other: Blood Donation, Other: Urine Donation, Other: Healthcare data linkageThis 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men who have been referred to secondary care with a suspicion of prostate cancer
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue donationBiopsies 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 | Cohort Observation |
| Blood DonationPhlebotomy 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 | Cohort Observation |
| Urine DonationUrine will be collected prior to prostate biopsy | Other | Cohort Observation |
| Healthcare data linkageMen will consent to healthcare data linkage via national databases. | Other | Cohort Observation |
Primary outcome
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
Time to metastases in men with prostate cancer
Time frame: 3 years
Development of secondary cancers or cancer recurrence
Time to prostate cancer related death
Time frame: 3 years
Time to prostate cancer related death in men diagnosed with prostate cancer
4 secondary outcomes
Time to new prostate cancer in men without cancer at baseline
Time frame: 3 years
Time to cancer progression in men identified with prostate cancer at baseline
Time frame: 3 years
Time to prostate cancer specific death in all men
Time frame: 3 years
Time to all-cause death in all men
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 34218972Marsden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hashim U Ahmed, FRCS principal investigator
Imperial College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University College, London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of clinically significant prostate cancer confirmed on biopsy, defined as any Gleason pattern 7 or greater (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04060589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.