Clinical trial · Interventional
Comparison of Diagnostic Accuracy of Luminal Index and MP MRI for Accelerated deTEction of Significant Prostate Cancer
A Comparison of the Diagnostic Accuracy of Luminal Index Magnetic Resonance Imaging and Multi-parametric Magnetic Resonance Imaging for the Accelerated Detection of Significant Prostate Cancer
- 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)
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
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LI-MRI targeted prostate biopsy | Diagnostic Test | — | UNRESOLVED |
| Luminal Index MRI (LI-MRI) | Diagnostic Test | — | UNRESOLVED |
| Plasma methylation signature (ctMethSig) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRI scan
- description
- Mp-MRI, LI-MRI, plasma DNA methylation signature (optional)
- interventionNames
- Diagnostic Test: Luminal Index MRI (LI-MRI)
- Diagnostic Test: LI-MRI targeted prostate biopsy
- Diagnostic Test: Plasma methylation signature (ctMethSig)
Primary outcomes (1)
- measure
- Diagnostic accuracy of mp-MRI and LI-MRI
- timeFrame
- 3 years
- description
- 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.
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men with clinically suspected prostate cancer and referred for prostate MRI * Willing and able to provide a written informed consent Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDAl-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 Apr;137(4):611-618. doi: 10.1111/bju.70108. Epub 2026 Jan 25. PMID 41582606