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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02689271
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date February 12, 2016
First Posted Date February 23, 2016
Last Update Posted Date March 27, 2020
Actual Study Start Date April 2016
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2016)		 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 Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr
Official Title 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 Observational
Study Design 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 Prostate Cancer
Intervention 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. doi: 10.1186/s12885-016-2856-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 18, 2016)		 365
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02689271
Other Study ID Numbers 15/0692
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party University College, London
Original Responsible Party Same as current
Current Study Sponsor University College, London
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University College, London
Verification Date March 2020