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.
Adult
Aged
Early Detection of Cancer
/ adverse effects
False Negative Reactions
Humans
Image-Guided Biopsy
/ adverse effects
Magnetic Resonance Imaging, Interventional
/ adverse effects
Male
Middle Aged
Multicenter Studies as Topic
Multimodal Imaging
Predictive Value of Tests
Prospective Studies
Prostatic Neoplasms
/ pathology
Randomized Controlled Trials as Topic
Reproducibility of Results
Scotland
Ultrasonography, Interventional
Multiparametric magnetic resonance imaging
Prostate biopsy
Prostate cancer
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
21 Nov 2019
21 Nov 2019
Historique:
received:
28
07
2019
accepted:
23
09
2019
entrez:
23
11
2019
pubmed:
23
11
2019
medline:
18
6
2020
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov, NCT02745496. Retrospectively registered on 20 April 2016.
Identifiants
pubmed: 31752954
doi: 10.1186/s13063-019-3746-0
pii: 10.1186/s13063-019-3746-0
pmc: PMC6868804
doi:
Banques de données
ClinicalTrials.gov
['NCT02745496']
Types de publication
Clinical Trial Protocol
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
638Subventions
Organisme : Prostate Cancer UK
ID : CSO-PG13-005
Pays : United Kingdom
Références
N Engl J Med. 2009 Mar 26;360(13):1320-8
pubmed: 19297566
J Urol. 2013 Nov;190(5):1721-1727
pubmed: 23727310
Clin Radiol. 2013 Oct;68(10):1016-23
pubmed: 23827086
Oncotarget. 2018 Mar 23;9(22):15997-16007
pubmed: 29662622
Radiology. 2008 Aug;248(2):531-9
pubmed: 18539890
Prostate Cancer Prostatic Dis. 2010 Mar;13(1):71-7
pubmed: 19786982
Rev Sci Instrum. 2009 Oct;80(10):104301
pubmed: 19895076
World J Urol. 2017 Feb;35(2):213-220
pubmed: 27236302
AJR Am J Roentgenol. 2004 Oct;183(4):1079-83
pubmed: 15385308
J Natl Cancer Inst. 2007 Sep 19;99(18):1395-400
pubmed: 17848671
BMJ. 2012 Jan 09;344:d7894
pubmed: 22232535