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

University College London (UCL) logo

University College London (UCL)

Status

Completed

Conditions

Prostate Cancer

Treatments

Other: MRI

Study type

Observational

Funder types

Other

Identifiers

NCT02689271
15/0692

Details and patient eligibility

About

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

Full 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

Enrollment

365 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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