Comparing biparametric to multiparametric MRI in the diagnosis of clinically significant prostate cancer in biopsy-naive men (PRIME): a prospective, international, multicentre, non-inferiority within-patient, diagnostic yield trial protocol
,
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,
Joke Van Egmond
Affiliations
3University College London
Jonathan J Deeks
professor of biostatistics
Chris Brew-Graves
4 Surgical and Interventional Trials Unit (SITU), Division of Surgery and Interventional Science, University College London, London, UK
Yemisi Takwoingi
Department of Applied Health Sciences, University of Birmingham, Birmingham, UK
Aiman Haider
Department of Histopathology, University College London Hospitals NHS Foundation Trust, London, UK
Clare Allen
Division of Surgery and Interventional Science, University College London, London, UK
Alex Freeman
Department of Histopathology, University College London Hospitals NHS Foundation Trust, London, UK
Mark Emberton
Urology, University College London Hospitals NHS Foundation Trust, London, UK
Antti Rannikko
University of Helsinki, Helsinki, Finland
John Wilkinson
Medicines and Healthcare products Regulatory Agency (MHRA), London, UK
Daniel Margolis
Enrique Gomez Gomez
Sangeet Ghai
Alex Kirkham
Department of Radiology, University College London Hospitals NHS Foundation Trust, London, UK
Veeru Kasivisvanathan
Division Of Surgery and Interventional Sciences, University College London, London, UK
Caroline M Moore
Division of Surgery & Interventional Science, University College London, London, UK
Hazel McBain
Anders Bjartell
Department of Translational Medicine, Lund University, Malmö, Sweden
Paula Lorgelly
Department of Applied Health Research, University College London, London, UK
Pramit Khetrapal
2 Division of Surgery and Interventional Science, University College London, London, UK
Shonit Punwani
Centre for Medical Imaging, University College London, London, UK
Nicola Muirhead
National Cancer Imaging Translational Accelerator, University College London, London, UK
Ridhi Agarwal
University of Birmingham, Birmingham, UK
Philip Ryan
Caroline S Clarke
Research Department of Primary Care and Population Health, University College London, UCL Medical School, London, UK
Aqua Asif
Division of Surgery and Interventional Science, University College London, London, UK
Peter Albertsen
Surgery/Urology, UConn Health, Farmington, Connecticut, USA
Alexander Ng
Division of Surgery and Interventional Science, University College London, London, UK
Francesco Giganti
Division of Surgery & Interventional Science, University College London, London, UK
Louise Dickinson
Jeremy Grummet
Vinson Wai-Shun Chan
Division of Surgery and Interventional Science, University College London, London, UK
Arjun Nathan
Clinical Effectiveness Unit, Royal College of Surgeons of England, London, London, UK
Marimo Rossiter
Réka Novotta
Tushar Narain
Antonette Andrews
Valeria Panebianco
Lance Mynderse
Adam Froemming
Naoki Takahasi
Tristan Barrett
Raphaële Renard-Penna
Vibeke Løgager
Department of Radiology, Herlev & Gentofte University Hospital, Herlev, Denmark
Lars Boesen
Department of Urological Research, Herlev & Gentofte University Hospital, Herlev, Denmark
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.
