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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02689271
Acronym
INNOVATE
Enrollment
365
Registered
2016-02-23
Start date
2016-04-30
Completion date
2019-12-31
Last updated
2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

MRI, Magnetic resonance imaging, Biomarkers, Fluidics, Diffusion MRI

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

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

Interventions

OTHERMRI

VERDICT diffusion-weighted microstructure imaging sequence

Sponsors

University College, London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of VERDICT MRI3 - 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026