A1 Refereed original research article in a scientific journal
Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial
Authors: Ivan Jambor, Janne Verho, Otto Ettala, Juha Knaapila, Pekka Taimen, Kari T. Syvänen, Aida Kiviniemi, Esa Kähkönen, Ileana Montoya Perez, Marjo Seppänen, Antti Rannikko, Outi Oksanen, Jarno Riikonen, Sanna Mari Vimpeli, Tommi Kauko, Harri Merisaari, Markku Kallajoki, Tuomas Mirtti, Tarja Lamminen, Jani Saunavaara, Hannu J. Aronen, Peter J. Boström
Publisher: PUBLIC LIBRARY SCIENCE
Publication year: 2019
Journal: PLoS Medicine
Journal acronym: PLOS MED
Article number: ARTN e1002813
Volume: 16
Issue: 6
Number of pages: 14
ISSN: 1549-1277
eISSN: 1549-1676
DOI: https://doi.org/10.1371/journal.pmed.1002813
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/41684321
Background: Magnetic resonance imaging (MRI) combined with targeted biopsy (TB) is increasingly used in men with clinically suspected prostate cancer (PCa), but the long acquisition times, high costs, and inter-center/reader variability of routine multiparametric prostate MRI limit its wider adoption.
Methods and findings: The aim was to validate a previously developed unique MRI acquisition and reporting protocol, IMPROD biparametric MRI (bpMRI) (NCT01864135), in men with a clinical suspicion of PCa in a multi-institutional trial (NCT02241122). IMPROD bpMRI has average acquisition time of 15 minutes (no endorectal coil, no intravenous contrast use) and consists of T2-weighted imaging and 3 separate diffusion-weighed imaging acquisitions. Between February 1, 2015, and March 31, 2017, 364 men with a clinical suspicion of PCa were enrolled at 4 institutions in Finland. Men with an equivocal to high suspicion (IMPROD bpMRI Likert score 3-5) of PCa had 2 TBs of up to 2 lesions followed by a systematic biopsy (SB). Men with a low to very low suspicion (IMPROD bpMRI Likert score 1-2) had only SB. All data and protocols are freely available. The primary outcome of the trial was diagnostic accuracy-including overall accuracy, sensitivity, specificity, negative predictive value (NPV), and positive predictive value-of IMPROD bpMRI for clinically significant PCa (SPCa), which was defined as a Gleason score >= 3 + 4 (Gleason grade group 2 or higher). In total, 338 (338/364, 93%) prospectively enrolled men completed the trial. The accuracy and NPV of IMPROD bpMRI for SPCa were 70% (113/161) and 95% (71/75) (95% CI 87%-98%), respectively. Restricting the biopsy to men with equivocal to highly suspicious IMPROD bpMRI findings would have resulted in a 22% (75/338) reduction in the number of men undergoing biopsy while missing 4 (3%, 4/146) men with SPCa. The main limitation is uncertainty about the true PCa prevalence in the study cohort, since some of the men may have PCa despite having negative biopsy findings.
Conclusions: IMPROD bpMRI demonstrated a high NPV for SPCa in men with a clinical suspicion of PCa in this prospective multi-institutional clinical trial.
Downloadable publication This is an electronic reprint of the original article. |