Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04060589
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Collaborators:
Medical Research Council
Cancer Research UK
Imperial College London
King's College London
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment
Prostate Cancer Other: Tissue donation Other: Blood Donation Other: Urine Donation Other: Healthcare data linkage

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. Time to metastases in men with prostate cancer [ Time Frame: 3 years ]
    Development of secondary cancers or cancer recurrence

  3. Time to prostate cancer related death [ Time Frame: 3 years ]
    Time to prostate cancer related death in men diagnosed with prostate cancer


Secondary Outcome Measures :
  1. 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

  2. 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. Time to prostate cancer specific death in all men [ Time Frame: 3 years ]
    Time to prostate cancer specific death in all men

  4. Time to all-cause death in all men [ Time Frame: 3 years ]
    Time to all-cause death in all men



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men who have been referred to secondary care with a suspicion of prostate cancer
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060589


Contacts
Layout table for location contacts
Contact: Neil McCartan 02076799280 n.mccartan@ucl.ac.uk

Sponsors and Collaborators
University College, London
Medical Research Council
Cancer Research UK
Imperial College London
King's College London
Investigators
Layout table for investigator information
Principal Investigator: Hashim U Ahmed, FRCS Imperial College London
Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04060589    
Other Study ID Numbers: 123973
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Prostate cancer
Magnetic resonance imaging-targeted biopsy
Biomarker
MRI-based diagnostic pathway
magnetic resonance imaging
targeted biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases