Clinical trial · Observational
CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr
NCT02689271CI-TRIAL-00044304INNOVATEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic accuracy of VERDICT MRI
- timeFrame
- 3 - 6 months (after targeted biopsy or follow up MRI)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSingh 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 35916679
- DERIVEDJohnston 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 27769214