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CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr (INNOVATE)
This study is currently recruiting participants.
Verified October 2016 by University College, London
Sponsor:
University College, London
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
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Purpose
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
| Condition | Intervention |
|---|---|
| Prostate Cancer | Other: MRI |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr |
Resource links provided by NLM:
Further study details as provided by University College, London:
Primary Outcome Measures:
- 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.
Biospecimen Retention: Samples With DNA
Blood and urine samples
| Estimated Enrollment: | 365 |
| Study Start Date: | April 2016 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: MRI
VERDICT diffusion-weighted microstructure imaging sequence
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Men with suspected prostate cancer
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02689271
Please refer to this study by its ClinicalTrials.gov identifier: NCT02689271
Locations
| United Kingdom | |
| University College London Hospital | Recruiting |
| London Borough of Camden, United Kingdom, NW12BU | |
| Contact: Edward Johnston edward.johnston@nhs.net | |
Sponsors and Collaborators
University College, London
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT02689271 History of Changes |
| Other Study ID Numbers: |
15/0692 |
| Study First Received: | February 12, 2016 |
| Last Updated: | October 25, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by University College, London:
|
MRI Magnetic resonance imaging Biomarkers Fluidics Diffusion MRI |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on July 14, 2017