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

TY - JOUR

T1 - A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer

T2 - MULTIPROS study protocol

AU - Szewczyk-Bieda, Magdalena

AU - Wei, Cheng

AU - Coll, Katherine

AU - Gandy, Stephen

AU - Donnan, Peter

AU - Ragupathy, Senthil Kumar Arcot

AU - Singh, Paras

AU - Wilson, Jennifer

AU - Nabi, Ghulam

PY - 2019/11/21

Y1 - 2019/11/21

N2 - 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.

AB - 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.

KW - Multiparametric magnetic resonance imaging

KW - Prostate biopsy

KW - Prostate cancer

UR - https://www.scopus.com/pages/publications/85075450525

U2 - 10.1186/s13063-019-3746-0

DO - 10.1186/s13063-019-3746-0

M3 - Article

C2 - 31752954

SN - 1745-6215

VL - 20

SP - 1

EP - 8

JO - Trials

JF - Trials

M1 - 638

ER -