Prostate Cancer, Prostate Neoplasm
Conditions
Brief summary
Multiparametric magnetic resonance imaging (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively before men undergo biopsy. Before these techniques are translated clinically, robust histological and clinical validation is required. This study aims to clinically validate advanced MRI techniques in a cohort of men suspected with prostate cancer. Histological analysis of men undergoing biopsy, +/- prostatectomy will be used for biological validation of VERDICT; Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging (LWI). In particular, prostatectomy specimens will be processed using 3-D printed patient-specific moulds to allow for accurate MRI and histology mapping.
Interventions
DIAGNOSTIC_TESTVERDICT MRI
Advanced Diffusion Model
DIAGNOSTIC_TESTLuminal Index Imaging
Advanced T2 mapping
Sponsors
University College, London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Men aged 18-90 with a clinical suspicion of prostate cancer * No contraindication to MRI
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 * Ongoing hormonal treatment for prostate cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of VERDICT MRI | 2 years | Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone |
| Diagnostic accuracy of Luminal Water Imaging (LWI) | 2 years | Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone |
Secondary
| Measure | Time frame |
|---|---|
| The proportions of true positives with index tests is the same as mpMRI. | 2 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Machine learning algorithms can predict histology from MRI. | 3 years | Number of correct predictions of gleason grade in men who undergo biopsy or prostatectomy. |
Countries
United Kingdom
Contacts
Primary ContactJoey Clemente
Outcome results
None listed