Jonathan J Deeks, Chris Brew-Graves, Yemisi Takwoingi, Aiman Haider, Clare Allen, Alex Freeman, Mark Emberton, Antti Rannikko, John Wilkinson, Daniel Margolis, Enrique Gomez Gomez, Sangeet Ghai, Alex Kirkham, Veeru Kasivisvanathan, Caroline M Moore, Hazel McBain, Anders Bjartell, Paula Lorgelly, Pramit Khetrapal, Shonit Punwani, Nicola Muirhead, Ridhi Agarwal, Philip Ryan, Caroline S Clarke, Aqua Asif, Peter Albertsen, Alexander Ng, Francesco Giganti, Louise Dickinson, Jeremy Grummet, Vinson Wai-Shun Chan, Arjun Nathan, Marimo Rossiter, Réka Novotta, Tushar Narain, Antonette Andrews, Valeria Panebianco, Lance Mynderse, Adam Froemming, Naoki Takahasi, Tristan Barrett, Raphaële Renard-Penna, Vibeke Løgager, Lars Boesen, Lars Budäus, Tho Pham, Jing Yi Jessica Weng, Wim Witjes, Christien Caris, and Joke Van Egmond
Introduction Prostate MRI is a well-established tool for the diagnostic work-up for men with suspected prostate cancer (PCa). Current recommendations advocate the use of multiparametric MRI (mpMRI), which is composed of three sequences: T2-weighted sequence (T2W), diffusion-weighted sequence (DWI) and dynamic contrast-enhanced sequence (DCE). Prior studies suggest that a biparametric MRI (bpMRI) approach, omitting the DCE sequences, may not compromise clinically significant cancer detection, though there are limitations to these studies, and it is not known how this may affect treatment eligibility. A bpMRI approach will reduce scanning time, may be more cost-effective and, at a population level, will allow more men to gain access to an MRI than an mpMRI approach.Methods Prostate Imaging Using MRI±Contrast Enhancement (PRIME) is a prospective, international, multicentre, within-patient diagnostic yield trial assessing whether bpMRI is non-inferior to mpMRI in the diagnosis of clinically significant PCa. Patients will undergo the full mpMRI scan. Radiologists will be blinded to the DCE and will initially report the MRI using only the bpMRI (T2W and DWI) sequences. They will then be unblinded to the DCE sequence and will then re-report the MRI using the mpMRI sequences (T2W, DWI and DCE). Men with suspicious lesions on either bpMRI or mpMRI will undergo prostate biopsy. The main inclusion criteria are men with suspected PCa, with a serum PSA of ≤20 ng/mL and without prior prostate biopsy. The primary outcome is the proportion of men with clinically significant PCa detected (Gleason score ≥3+4 or Gleason grade group ≥2). A sample size of at least 500 patients is required. Key secondary outcomes include the proportion of clinically insignificant PCa detected and treatment decision.Ethics and dissemination Ethical approval was obtained from the National Research Ethics Committee West Midlands, Nottingham (21/WM/0091). Results of this trial will be disseminated through peer-reviewed publications. Participants and relevant patient support groups will be informed about the results of the trial.Trial registration number NCT04571840.