CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr
INNOVATE
1 other identifier
observational
365
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2016
CompletedFirst Posted
Study publicly available on registry
February 23, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 27, 2020
March 1, 2020
3.7 years
February 12, 2016
March 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Interventions
VERDICT diffusion-weighted microstructure imaging sequence
Eligibility Criteria
Men with suspected prostate cancer
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University College London Hospital
Camden, NW12BU, United Kingdom
Related Publications (2)
Singh S, Rogers H, Kanber B, Clemente J, Pye H, Johnston EW, Parry T, Grey A, Dinneen E, Shaw G, Heavey S, Stopka-Farooqui U, Haider A, Freeman A, Giganti F, Atkinson D, Moore CM, Whitaker HC, Alexander DC, Panagiotaki E, Punwani S. Avoiding Unnecessary Biopsy after Multiparametric Prostate MRI with VERDICT Analysis: The INNOVATE Study. Radiology. 2022 Dec;305(3):623-630. doi: 10.1148/radiol.212536. Epub 2022 Aug 2.
PMID: 35916679DERIVEDJohnston 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.
PMID: 27769214DERIVED
Biospecimen
Blood and urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2016
First Posted
February 23, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
March 27, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share