1. 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.
- Author
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Szewczyk-Bieda, Magdalena, Wei, Cheng, Coll, Katherine, Gandy, Stephen, Donnan, Peter, Ragupathy, Senthil Kumar Arcot, Singh, Paras, Wilson, Jennifer, and Nabi, Ghulam
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PROSTATE biopsy , *EXOCRINE glands , *PROSTATE cancer , *MAGNETIC resonance imaging , *ENDORECTAL ultrasonography , *THERAPEUTICS , *BIOPSY , *CLINICAL trials , *COMPARATIVE studies , *DIAGNOSTIC errors , *DIAGNOSTIC imaging , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL cooperation , *PROSTATE tumors , *RESEARCH , *ULTRASONIC imaging , *EVALUATION research , *PREDICTIVE tests , *EARLY detection of cancer ,RESEARCH evaluation - 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. [ABSTRACT FROM AUTHOR]- Published
- 2019
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