Inclusion criteria, exclusion criteria and study summary
Multi-parametric Magnetic Resonance Imaging (mp-MRI) has become the standard of care in the diagnostic work-up of patients with suspected prostate cancer (PCa). Using a 45-50 minute MRI protocol, the technique has high sensitivity (> 90%) for detection of clinically significant disease. However, it has several limitations that should be addressed, specifically: a) only about to 1 in 2 men with suspicious lesions at MRI have significant tumour at biopsy (i.e.: there is a need for improved specificity); b) mp-MRI often suffers from image artefacts causing difficulty in scan interpretation (i.e.: there is a need for improved image quality); c) there is growing concern on the safety of contrast agents used for MRI (i.e.: there is a need to reduce contrast usage). Recently, a new MRI technology named Luminal Index MRI (LI-MRI) has been introduced. LI-MRI can be easily set-up on any existing clinical MRI scanner and could replace the standard 45-50 minute mp-MRI with single 5-10 minute scan. Preliminary studies showed that, compared to mp-MRI, LI-MRI matches sensitivity, improves specificity, is significantly less prone to image artifacts and does not require the use of contrast agents. CLIMATE will be a prospective, multi-centre, non-randomised comparative study of mp-MRI and LI-MRI recruiting men with clinical suspicion of prostate cancer that should undergo mp-MRI as part of their standard clinical care. All participants will undergo both mp-MRI and LI-MRI with targeted biopsies performed when suspicious lesion are detected. The primary aim will be to compare the diagnostic accuracy of LI-MRI and mp-MRI for the detection of significant cancer. Secondary aims will be to compare the proportions of men over diagnosed with non-harmful tumours based on mp-MRI and LI-MRI, to determine the reproducibility between radiologists in scoring LI-MRI and to correlate LI-MRI quantitative metrics with tumour aggressiveness.
