Abstract
Background
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.
Methods and materials
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.
Discussion
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.
Trial registration
ClinicalTrials.gov, NCT02745496. Retrospectively registered on 20 April 2016.
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Details
1 Ninewells Hospital, Department of Clinical Radiology, Dundee, UK (GRID:grid.416266.1) (ISNI:0000 0000 9009 9462)
2 University of Dundee, Ninewells Hospital, Division of Imaging Science and Technology, School of Medicine, Dundee, UK (GRID:grid.416266.1)
3 University of Dundee, Ninewells Hospital, Tayside Clinical Trials Unit (TCTU), Tayside Medical Science Centre (TASC), Dundee, UK (GRID:grid.416266.1)
4 Ninewells Hospital, Department of Medical Physics, Dundee, UK (GRID:grid.416266.1) (ISNI:0000 0000 9009 9462)
5 University of Dundee, Division of Population Health Genomics, Dundee, UK (GRID:grid.8241.f) (ISNI:0000 0004 0397 2876)
6 Aberdeen Royal Infirmary, Department of Clinical Radiology, Aberdeen, UK (GRID:grid.417581.e) (ISNI:0000 0000 8678 4766)
7 Royal Free Hospital, Royal Free London NHS Foundation Trust, London, UK (GRID:grid.426108.9) (ISNI:0000 0004 0417 012X)
8 Ninewells Hospital, Department of Clinical Pathology, Dundee, UK (GRID:grid.416266.1) (ISNI:0000 0000 9009 9462)