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ReIMAGINE Prostate Cancer Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04060589
Recruitment Status : Active, not recruiting
First Posted : August 19, 2019
Last Update Posted : April 11, 2022
Sponsor:
Collaborators:
Medical Research Council
Cancer Research UK
Imperial College London
King's College London
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date August 15, 2019
First Posted Date August 19, 2019
Last Update Posted Date April 11, 2022
Actual Study Start Date September 3, 2019
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 15, 2019)
  • 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
  • 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
  • Time to prostate cancer specific death in all men [ Time Frame: 3 years ]
    Time to prostate cancer specific death in all men
  • Time to all-cause death in all men [ Time Frame: 3 years ]
    Time to all-cause death in all men
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men who have been referred to secondary care with a suspicion of prostate cancer
Condition Prostate Cancer
Intervention
  • 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.
Study Groups/Cohorts 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.
Interventions:
  • Other: Tissue donation
  • Other: Blood Donation
  • Other: Urine Donation
  • Other: Healthcare data linkage
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 15, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04060589
Other Study ID Numbers 123973
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party University College, London
Original Responsible Party Same as current
Current Study Sponsor University College, London
Original Study Sponsor Same as current
Collaborators
  • Medical Research Council
  • Cancer Research UK
  • Imperial College London
  • King's College London
Investigators
Principal Investigator: Hashim U Ahmed, FRCS Imperial College London
PRS Account University College, London
Verification Date April 2022