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OpenTrials
Completed

NCT Number: NCT02689271

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University College London Hospital

Camden, NW12BU, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

VERDICT diffusion-weighted microstructure imaging sequence

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Acronym: INNOVATE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2016
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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