The 'Comparison of diagnostic accuracy of Luminal Index and standard of care MRI for Accelerated deTEction of prostate cancer' (CLIMATE) trial protocol.

[INTRODUCTION AND OBJECTIVES] Luminal Index magnetic resonance imaging (LI-MRI) is a novel technique that has recently been proposed for prostate cancer (PCa) characterisation. It is based on multi-echo T2-weighted sequences and requires <10 min to be performed. However, evidence on its diagnostic performance in the diagnostic evaluation of PCa is lacking. The 'Comparison of diagnostic accuracy of Luminal Index and standard of care MRI for Accelerated deTEction of prostate cancer' (CLIMATE) trial aims to compare the diagnostic accuracy of LI-MRI and standard of care (SOC) MRI (multiparametric or biparametric MRI) for the detection of clinically significant PCa (csPCa).

[TRIAL DESIGN] The CLIMATE trial is a prospective, multicentre, paired, non-randomised comparative trial of LI-MRI and SOC MRI targeted biopsy in participants with clinically suspected PCa.

[ENDPOINTS] The primary endpoint of the trial is to compare the per-participant diagnostic accuracy of LI-MRI and SOC MRI for csPCa using targeted biopsies as the standard of reference.

[PATIENTS AND METHODS] Adult men (aged ≥18 years) with clinical suspicion of PCa and no prior PCa diagnosis or treatment will be invited. Each participant will undergo LI-MRI and SOC MRI in a single scan session, with each test interpreted without knowledge of the other test images or results. LI-MRI and SOC MRI will be reported on a 1-5 scale for suspicion of tumour (Likert scale or Prostate Imaging-Reporting and Data System). Targeted biopsies will be taken for any suspicious lesions detected, defined as MRI score of ≥3.

[TRIAL REGISTRATION] ClinicalTrials.gov Registry (NCT05020522).