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

This study is currently recruiting participants.

See

Contacts and Locations

Verified October 2016 by University College, London

Sponsor:

Information provided by (Responsible Party):

University College, London

ClinicalTrials.gov Identifier:

NCT02689271

First received: February 12, 2016

Last updated: October 25, 2016

Last verified: October 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

February 12, 2016

Last Updated Date

October 25, 2016

Start Date ^ICMJE

April 2016

Estimated Primary Completion Date

March 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02689271 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Blood and urine samples

Sampling Method

Non-Probability Sample

Study Population

Men with suspected prostate cancer

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Other: MRI

VERDICT diffusion-weighted microstructure imaging sequence

Study Groups/Cohorts

Not Provided

Publications *

Johnston E, Pye H, Bonet-Carne E, Panagiotaki E, Patel D, Galazi M, Heavey S, Carmona L, Freeman A, Trevisan G, Allen C, Kirkham A, Burling K, Stevens N, Hawkes D, Emberton M, Moore C, Ahmed HU, Atkinson D, Rodriguez-Justo M, Ng T, Alexander D, Whitaker H, Punwani S. INNOVATE: A prospective cohort study combining serum and urinary biomarkers with novel diffusion-weighted magnetic resonance imaging for the prediction and characterization of prostate cancer. BMC Cancer. 2016 Oct 21;16(1):816.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

365

Estimated Completion Date

March 2018

Estimated Primary Completion Date

March 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Men referred to 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

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02689271

Other Study ID Numbers ^ICMJE

15/0692

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

University College, London

Study Sponsor ^ICMJE

University College, London

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

University College, London

Verification Date

October 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top