Comparison of Diagnostic Accuracy of Luminal Index and MP MRI for Accelerated deTEction of Significant Prostate Cancer

NCT05020522 | Unknown DMC

• 1 other identifier: 281621
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-parametric (mp) MRI has now internationally been incorporated as standard of care in the work-up of participants with suspected prostate cancer. The standard mpMRI protocol requires 30-45 minutes to be performed and has a sensitivity and specificity of approximately 90% and 50% for the detection of clinically significant prostate cancer. Compared to the non-targeted systematic transrectal ultrasound (TRUS) biopsy approach in men with clinically suspected prostate cancer (e.g.: elevated PSA), performing mpMRI as a triage test allows to detect clinically significant cancer in more men (38% vs 26%) and clinically insignificant cancer in less men (9% vs 22%), while avoiding biopsy in roughly one third of men. However, there is need for improvement in the prostate diagnostic pathway even after incorporation of mp-MRI, specifically mpMRI can miss significant cancer in around 10% of cases and only 50% of positive scans turn out to harbor significant cancer at biopsy. Moreover, the key functional imaging sequence of mp-MRI (i.e.: DWI) often suffers from image artifacts causing difficulty in scan interpretation. To address these issues the investigators aim to investigate Luminal Index MRI (LI-MRI), a novel method of MR imaging that requires only up to 10 minutes to be performed and doesn't require the use of contrast media. LI-MRI has shown promising results for the characterization of prostate cancer. In this study the diagnostic performance of LI-MRI and mpMRI for the detection of prostate cancer will be directly compared.

Conditions

Prostate Cancer

Keywords

Magnetic Resonance Imaging; Luminal Index MRI; Methylation Signature; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of mp-MRI and LI-MRI

  Comparison of per-participant diagnostic accuracy of mp-MRI and LI-MRI for the detection of clinically significant prostate cancer (i.e. Gleason 3+4 or higher). Two endpoints are included in the primary outcome: difference in sensitivity and difference in specificity.

  3 years

Secondary Outcomes (10)

• Diagnostic accuracy of LI-MRI as an add-on test

  3 years

• Proportion of correct clinical recommendation

  3 years

• Per-lesion diagnostic accuracy of mp-MRI and LI-MRI

  3 years

• Proportion of non-significant cancer detection

  3 years

• Value of MRI in diagnostic models

  3 years

Other Outcomes (1)

• ctMethSig and risk of metastases

  3 years

Study Arms (1)

MRI scan

OTHER

Mp-MRI, LI-MRI, plasma DNA methylation signature (optional)

Diagnostic Test: Luminal Index MRI (LI-MRI); Diagnostic Test: LI-MRI targeted prostate biopsy; Diagnostic Test: Plasma methylation signature (ctMethSig)

Interventions

Luminal Index MRI (LI-MRI) DIAGNOSTIC_TEST

Multiecho T2 sequence; eventual biopsy of lesion(s) detected with LI-MRI only.

MRI scan

LI-MRI targeted prostate biopsy DIAGNOSTIC_TEST

Biopsy targeted to suspicious lesions detected with LI-MRI only

MRI scan

Plasma methylation signature (ctMethSig) DIAGNOSTIC_TEST

Blood sample.

MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with clinically suspected prostate cancer and referred for prostate MRI
• Willing and able to provide a written informed consent

You may not qualify if:

• Prostate specific antigen (PSA) level \> 20ng/ml within 6 months
• Previous diagnosis of prostate cancer
• Ongoing hormone treatment within 3 months prior to MRI, excluding antiandrogens or 5-alpha reductase inhibitors
• Contraindication to MRI scan
• Contraindication to administration of gadolinium-based contrast agents

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (1)

• Al-Hammouri T, Brembilla G, Brizmohun M, Tuazon J, Clemente J, Mathew M, Potyka I, Brew-Graves C, Markus J, Giganti F, Parry T, Haider A, Mallett S, Dudderidge T, Barrett T, Attard G, Moore C, Punwani S; CLIMATE Trial Management Group. The 'Comparison of diagnostic accuracy of Luminal Index and standard of care MRI for Accelerated deTEction of prostate cancer' (CLIMATE) trial protocol. BJU Int. 2026 Jan 25. doi: 10.1111/bju.70108. Online ahead of print.

  PMID: 41582606 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Shonit Punwani

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trial Manager

CONTACT

02076795279; ncita.climate@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Paired, non-randomised, comparative study

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 25, 2021
• Study Start: May 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)