Prostate Assessment using Comparative Interventions - Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial.

BACKGROUND: Multiparametric MRI (mpMRI) with contrast medium is recommended in the prostate cancer diagnostic pathway. It is unclear if MRI without contrast medium (biparametric [bp]) can be used instead whilst remaining sensitive to detection of clinically significant cancers. For those with a positive MRI, is image-fusion targeting better than visual-registration (cognitive) targeting in detecting clinically significant prostate cancer? And does bpMRI represent better value for money than mpMRI? A randomised controlled trial testing clinical utility and cost-effectiveness of these approaches is vital before changes in practice. METHODS: IP7-PACIFIC is a prospective, multicentre, co-enrolment trial with two randomisations and embedded economic evaluation. The first randomisation will evaluate non-inferiority of bpMRI compared to mpMRI in those with clinical suspicion of prostate cancer. Men with a suspicious MRI will undergo a second randomisation to evaluate if image-fusion targeting is superior to standard visual-registration targeted biopsy. Ethics committee approval has been granted by the London Bromley Research Ethics Committee. RESULTS: The primary objective for Randomisation 1 is to determine non-inferiority of bpMRI to detect Gleason score ≥ 7 [ISUP Grade Group ≥2] cancer compared to mpMRI. The objective for Randomisation 2 is to determine if image-fusion targeted biopsy is superior to visual-registration targeted biopsy. An internal pilot phase will enrol 700 patients; the overall recruitment target is 3600. DISCUSSION: IP7-PACIFIC aims to provide randomised comparative evidence for the clinical utility and cost-effectiveness of using bpMRI and image-fusion biopsy. The findings will inform guidelines. The sequential randomised co-enrolment design allows simultaneous evaluation of two research questions and avoids heterogeneity of trial populations. By contrast to previous paired-cohort studies, the randomised design will reduce reporter bias, providing the highest level of diagnostic evidence.