TY - JOUR
T1 - A protocol for the VISION study
T2 - An indiVidual patient data meta-analysis of randomised trials comparing MRI-targeted biopsy to standard transrectal ultraSound guided bIopsy in the detection of prOstate cancer
AU - VISION study collaborators
AU - Kasivisvanathan, Veeru
AU - Chan, Vinson Wai Shun
AU - Clement, Keiran D.
AU - Levis, Brooke
AU - Haider, Masoom
AU - Agarwal, Ridhi
AU - Emberton, Mark
AU - Pond, Gregory R.
AU - Takwoingi, Yemisi
AU - Klotz, Laurence
AU - Moore, Caroline M.
N1 - Publisher Copyright:
© 2022 Kasivisvanathan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2022/2/3
Y1 - 2022/2/3
N2 - Background Transrectal ultrasound (TRUS) guided biopsy for prostate cancer is prone to random and systemic error and has been shown to have a negative predictive value of 70%. PRECISION and PRECISE are among the first randomised studies to evaluate the new MRI-targeted biopsy (MRI-TB) pathway with a non-paired design to detect clinically significant prostate cancer and avoid unnecessary treatment. The trials' results individually demonstrated noninferiority of MRI-TB compared to TRUS biopsy. An individual patient data (IPD) meta-analysis was planned from the outset of the two trials in parallel and this IPD meta-analysis aims to further elucidate the utility of MRI-TB as the optimal diagnostic pathway for prostate cancer. Methods and materials This study is registered on PROSPERO (CRD42021249263). A search of Medline, Embase, Cochrane Central Register of Registered Trials (CENTRAL), Web of Science, and ClinicalTrials.gov was performed up until 4th February 2021. Only randomised controlled trials (PRECISE, PRECISION and other eligible trials) comparing the MRI-targeted biopsy pathway and traditional TRUS biopsy pathway will be included. The primary outcome of the review is the proportion of men diagnosed with clinically significant prostate cancer in each arm (Gleason ≥ 3+4 = 7). IPD and study-level data and characteristics will be sought from eligible studies. Analyses will be done primarily using an intention-to-treat approach, and a one-step IPD meta-analysis will be performed using generalised linear mixed models. A non-inferiority margin of 5 percentage points will be used. Heterogeneity will be quantified using the variance parameters from the mixed model. If there is sufficient data, we will investigate heterogeneity by exploring the effect of the different conducts of MRIs, learning curves of MRI reporting and MRI targeted biopsies.Trial registration: This systematic review is registered on PROSPERO (CRD42021249263)
AB - Background Transrectal ultrasound (TRUS) guided biopsy for prostate cancer is prone to random and systemic error and has been shown to have a negative predictive value of 70%. PRECISION and PRECISE are among the first randomised studies to evaluate the new MRI-targeted biopsy (MRI-TB) pathway with a non-paired design to detect clinically significant prostate cancer and avoid unnecessary treatment. The trials' results individually demonstrated noninferiority of MRI-TB compared to TRUS biopsy. An individual patient data (IPD) meta-analysis was planned from the outset of the two trials in parallel and this IPD meta-analysis aims to further elucidate the utility of MRI-TB as the optimal diagnostic pathway for prostate cancer. Methods and materials This study is registered on PROSPERO (CRD42021249263). A search of Medline, Embase, Cochrane Central Register of Registered Trials (CENTRAL), Web of Science, and ClinicalTrials.gov was performed up until 4th February 2021. Only randomised controlled trials (PRECISE, PRECISION and other eligible trials) comparing the MRI-targeted biopsy pathway and traditional TRUS biopsy pathway will be included. The primary outcome of the review is the proportion of men diagnosed with clinically significant prostate cancer in each arm (Gleason ≥ 3+4 = 7). IPD and study-level data and characteristics will be sought from eligible studies. Analyses will be done primarily using an intention-to-treat approach, and a one-step IPD meta-analysis will be performed using generalised linear mixed models. A non-inferiority margin of 5 percentage points will be used. Heterogeneity will be quantified using the variance parameters from the mixed model. If there is sufficient data, we will investigate heterogeneity by exploring the effect of the different conducts of MRIs, learning curves of MRI reporting and MRI targeted biopsies.Trial registration: This systematic review is registered on PROSPERO (CRD42021249263)
UR - http://www.scopus.com/inward/record.url?scp=85124002112&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0263345
DO - 10.1371/journal.pone.0263345
M3 - Article
C2 - 35113918
AN - SCOPUS:85124002112
SN - 1932-6203
VL - 17
JO - PLoS ONE
JF - PLoS ONE
IS - 2
M1 - e0263345
ER -
