ReIMAGINE Prostate Cancer Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-03

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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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

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Tissue donation

Intervention Type OTHER

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 Donation

Intervention Type OTHER

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 Donation

Intervention Type OTHER

Urine will be collected prior to prostate biopsy

Healthcare data linkage

Intervention Type OTHER

Men will consent to healthcare data linkage via national databases.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Urine Donation

Urine will be collected prior to prostate biopsy

Intervention Type OTHER

Healthcare data linkage

Men will consent to healthcare data linkage via national databases.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No