Clinical trial NCT04060589: ReIMAGINE Prostate Cancer Risk
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Prostate cancer
Magnetic resonance imaging-targeted biopsy
Biomarker
MRI-based diagnostic pathway
magnetic resonance imaging
targeted biopsy
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: Cancer Research UK
name: Imperial College London
name: King's College London
First posted: 2019-08-19
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men who have been referred to secondary care with a suspicion of prostate cancer

Brief 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Presence of clinically significant prostate cancer confirmed on biopsy, defined as any Gleason pattern 7 or greater
timeFrame: 6 weeks
measure: Time to metastases in men with prostate cancer
timeFrame: 3 years
measure: Time to prostate cancer related death
timeFrame: 3 years
Secondary outcomes:
measure: Time to new prostate cancer in men without cancer at baseline
timeFrame: 3 years
measure: Time to cancer progression in men identified with prostate cancer at baseline
timeFrame: 3 years
measure: Time to prostate cancer specific death in all men
timeFrame: 3 years
measure: Time to all-cause death in all men
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Hashim U Ahmed, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.