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

Prostate Cancer Clinical Trial

— INNOVATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689271
• Other study ID #: 15/0692
• Status: Completed
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• MRI
VERDICT diffusion-weighted microstructure imaging sequence

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	Camden

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of VERDICT 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.	3 - 6 months (after targeted biopsy or follow up MRI)