A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol.

There is growing evidence suggesting that multiparametric magnetic resonance imaging (mpMRI) is a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Improving early detection of clinically significant PCa with pre-biopsy mpMRI would very likely have advantages including optimising the diagnosis and treatment of diseases and diminishing patient anxiety.

This is a prospective multicentre study of pre-biopsy mpMRI diagnostic test accuracy with subgroup randomisation at a 1:1 ratio with respect to transrectal ultrasound (TRUS) and MRI/US fusion-guided biopsy or TRUS-only biopsy. It is designed as a single-gate study with a single set of inclusion criteria. The total duration of the recruitment phase was 48 months; however, this has now been extended to 66 months. A sample size of 600 participants is required.

The primary objective is to determine whether mpMRI can improve PCa detection and characterisation. The key secondary objective is to determine whether MRI/US fusion-guided biopsy can reduce the number of false-negative biopsies. Ethical approval was obtained from the East of Scotland Research Ethics Committee 1 (14/ES/1070) on 20 November 2014. The results of this study will be used for publication and presentation in national and international journals and at scientific conferences.

ClinicalTrials.gov, NCT02745496. Retrospectively registered on 20 April 2016.

Trials. 2019 Nov 21*** epublish ***

Magdalena Szewczyk-Bieda, Cheng Wei, Katherine Coll, Stephen Gandy, Peter Donnan, Senthil Kumar Arcot Ragupathy, Paras Singh, Jennifer Wilson, Ghulam Nabi

Department of Clinical Radiology, Ninewells Hospital, Dundee, DD1 9SY, UK., Division of Imaging Science and Technology, School of Medicine, University of Dundee, Ninewells Hospital, Dundee, DD1 9SY, UK., Tayside Clinical Trials Unit (TCTU), Tayside Medical Science Centre (TASC), University of Dundee, Ninewells Hospital, Dundee, DD1 9SY, UK., Department of Medical Physics, Ninewells Hospital, Dundee, DD1 9SY, UK., Division of Population Health Genomics, University of Dundee, Dundee, DD2 4BF, UK., Department of Clinical Radiology, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, UK., Royal Free London NHS Foundation Trust, Royal Free Hospital, London, NW3 2QG, UK., Department of Clinical Pathology, Ninewells Hospital, Dundee, DD1 9SY, UK., Division of Imaging Science and Technology, School of Medicine, University of Dundee, Ninewells Hospital, Dundee, DD1 9SY, UK. .