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CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr (INNOVATE)

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ClinicalTrials.gov Identifier: NCT02689271
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

Study Description
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Brief Summary:
To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer by better selecting patients who will benefit from diagnostic MRI and by improving the performance of the mp-MRI itself

Condition or disease Intervention/treatment
Prostate Cancer Other: MRI

Detailed Description:

Patients will undergo an advanced diffusion-weighted MRI sequence called VERDICT with the intention of better characterising prostate cancer. A panel of serum and urine biomarkers will also be analysed, which we hope will predict those patients who go on have a positive MRI.

OBJECTIVES:

  • To establish a fluidic marker - prostate MRI paradigm which: (i) utilises fluidic markers to rationalise selection of patients with significant prostate cancer; and (ii) improves the diagnostic accuracy of imaging over and above standard multiparametric (mp) MRI
  • Enable a pathway for rapid clinical evaluation of emerging fluidic markers and exosomes
  • Assess the repeatability of VERDICT MRI
  • Ascertain whether VERDICT derived quantitative parameters correlate with quantitative histological parameters
  • Develop a database of fluidic marker and VERDICT characterised, mp-MRI, histologically validated patients for subsequent exploratory and longitudinal outcome analysis
Study Design
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Study Type : Observational
Actual Enrollment : 365 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: MRI
    VERDICT diffusion-weighted microstructure imaging sequence

Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic accuracy of VERDICT MRI [ Time Frame: 3 - 6 months (after targeted biopsy or follow up MRI) ]
    Radiological assessment with added VERDICT MRI improves the specificity of mp-MRI for detection of significant prostate cancer by >10% above standard multi-parametric MRI alone.


Biospecimen Retention:   Samples With DNA
Blood and urine samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with suspected prostate cancer
Criteria

Inclusion Criteria:

  • Men referred to University College London Hospital (UCLH) for prostate mp-MRI following biopsy elsewhere and biopsy naive men presenting to UCLH with a clinical suspicion of prostate cancer.

Exclusion Criteria:

  • Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
  • Men unable to given informed consent
  • Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
  • On-going hormonal treatment for prostate cancer
  • Previous biopsy within 6 months of scheduled mp-MRI
Contacts and Locations
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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): NCT02689271


Locations
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United Kingdom
University College London Hospital
Camden, United Kingdom, NW12BU
Sponsors and Collaborators
University College, London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02689271    
Other Study ID Numbers: 15/0692
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University College, London:
MRI
Magnetic resonance imaging
Biomarkers
Fluidics
Diffusion MRI
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases