NCT04792138

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

March 2, 2021

Last Update Submit

March 8, 2021

Conditions

Prostate CancerProstate Neoplasm

Outcome Measures

Primary Outcomes (2)

  • Diagnostic accuracy of VERDICT MRI

    Quantitative assessment of VERDICT MRI reduces false positives by 10% compared to standard MRI alone

    2 years

  • Diagnostic accuracy of Luminal Water Imaging (LWI)

    Quantitative assessment of LWI reduces false positives by 10% compared to standard MRI alone

    2 years

Secondary Outcomes (1)

  • The proportions of true positives with index tests is the same as mpMRI.

    2 years

Other Outcomes (1)

  • Machine learning algorithms can predict histology from MRI.

    3 years

Study Arms (1)

Men suspected of Prostate Cancer

Diagnostic Test: VERDICT MRIDiagnostic Test: Luminal Index Imaging

Interventions

VERDICT MRIDIAGNOSTIC_TEST

Advanced Diffusion Model

Men suspected of Prostate Cancer
Luminal Index ImagingDIAGNOSTIC_TEST

Advanced T2 mapping

Men suspected of Prostate Cancer

Eligibility Criteria

Age18 Years - 90 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity. Men with clinical suspicion of prostate cancer.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of men presenting to our recruitment centre with suspicion of prostate cancer due to raised prostate specific antigen level or suspicious clinical examination.

You may qualify if:

  • Men aged 18-90 with a clinical suspicion of prostate cancer
  • No contraindication to MRI

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
  • Ongoing hormonal treatment for prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospital

London, United Kingdom

RECRUITING

Related Publications (1)

  • Singh S, Mathew M, Mertzanidou T, Suman S, Clemente J, Retter A, Papoutsaki MV, Smith L, Grussu F, Kasivisvanathan V, Grey A, Dinneen E, Shaw G, Carter M, Patel D, Moore CM, Atkinson D, Panagiotaki E, Haider A, Freeman A, Alexander D, Punwani S. Histo-MRI map study protocol: a prospective cohort study mapping MRI to histology for biomarker validation and prediction of prostate cancer. BMJ Open. 2022 Apr 8;12(4):e059847. doi: 10.1136/bmjopen-2021-059847.

    PMID: 35396316DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Prostatectomy and biopsy specimens

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Shonit Punwani

    University College, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joey Clemente

CONTACT

07886178028j.clemente@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 10, 2021

Study Start

October 23, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2023

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

GB(1)