eprintid: 10204691 rev_number: 10 eprint_status: archive userid: 699 dir: disk0/10/20/46/91 datestamp: 2025-02-13 08:34:31 lastmod: 2025-02-13 08:36:56 status_changed: 2025-02-13 08:34:31 type: article metadata_visibility: show sword_depositor: 699 creators_name: Twilt, JJ creators_name: Saha, A creators_name: Bosma, JS creators_name: Van Ginneken, B creators_name: Bjartell, A creators_name: Padhani, AR creators_name: Bonekamp, D creators_name: Villeirs, G creators_name: Salomon, G creators_name: Giannarini, G creators_name: Kalpathy-Cramer, J creators_name: Barentsz, J creators_name: Maier-Hein, KH creators_name: Rusu, M creators_name: Rouvière, O creators_name: Van den Bergh, R creators_name: Panebianco, V creators_name: Kasivisvanathan, V creators_name: Obuchowski, NA creators_name: Yakar, D creators_name: Elschot, M creators_name: Veltman, J creators_name: Fütterer, JJ creators_name: Huisman, H creators_name: De Rooij, M creators_name: Saha, A creators_name: Bosma, JS creators_name: Van Ginneken, B creators_name: Noordman, CR creators_name: Slootweg, I creators_name: Roest, C creators_name: Fransen, SJ creators_name: Sunoqrot, MRS creators_name: Bathen, TF creators_name: Rouw, D creators_name: Geerdink, J creators_name: Van Run, C creators_name: Groeneveld, M creators_name: Meakin, J creators_name: Immerzeel, JJFM creators_name: Yakar, D creators_name: Veltman, J creators_name: Fütterer, JJ creators_name: De Rooij, M creators_name: Huisman, H creators_name: Bjartell, A creators_name: Padhani, AR creators_name: Bonekamp, D creators_name: Villeirs, G creators_name: Salomon, G creators_name: Giannarini, G creators_name: Kalpathy-Cramer, J creators_name: Barentsz, J creators_name: Maier-Hein, KH creators_name: Rusu, M creators_name: Obuchowski, NA creators_name: Rouviere, O creators_name: Van den Bergh, R creators_name: Panebianco, V creators_name: Kasivisvanathan, V creators_name: Malakoti-Fard, A creators_name: Mačiūnien, A creators_name: Kawashima, A creators_name: Gaivão, AM creators_name: Moreira, ASL creators_name: Ponsiglione, A creators_name: Rappaport, A creators_name: Stanzione, A creators_name: Ciuvasovas, A creators_name: Turkbey, B creators_name: Keyzer, BD creators_name: Pedersen, BG creators_name: Eijlers, B creators_name: Chen, C creators_name: Riccardo, C creators_name: Alis, D creators_name: Courrech Staal, EFW creators_name: Thimansson, E creators_name: Jäderling, F creators_name: Langkilde, F creators_name: Aringhieri, G creators_name: Brembilla, G creators_name: Son, H creators_name: Van der Lelij, H creators_name: Raat, HPJ creators_name: Pikūnienė, I creators_name: Macova, I creators_name: Schoots, I creators_name: Caglic, I creators_name: Zawaideh, JP creators_name: Wallström, J creators_name: Bittencourt, LK creators_name: Khurram, M creators_name: Choi, MH creators_name: Takahashi, N creators_name: Tan, N creators_name: Franco, PN creators_name: Gutierrez, PA creators_name: the PI-CAI Consortium, title: Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer: An International, Paired, Noninferiority, Confirmatory Observer Study ispublished: pub divisions: UCL divisions: B02 divisions: C10 divisions: D16 keywords: Prostate cancer; Biparametric magnetic resonance imaging; Multiparametric magnetic resonance imaging; Dynamic contrast-enhanced imaging; Observer study; Noninferiority note: Copyright © 2024 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). abstract: Background and objective: Biparametric magnetic resonance imaging (bpMRI), excluding dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI), is a potential replacement for multiparametric MRI (mpMRI) in diagnosing clinically significant prostate cancer (csPCa). An extensive international multireader multicase observer study was conducted to assess the noninferiority of bpMRI to mpMRI in csPCa diagnosis. // Methods: An observer study was conducted with 400 mpMRI examinations from four European centers, excluding examinations with prior prostate treatment or csPCa (Gleason grade [GG] ≥2) findings. Readers assessed bpMRI and mpMRI sequentially, assigning lesion-specific Prostate Imaging Reporting and Data System (PI-RADS) scores (3–5) and a patient-level suspicion score (0–100). The noninferiority of patient-level bpMRI versus mpMRI csPCa diagnosis was evaluated using the area under the receiver operating curve (AUROC) alongside the sensitivity and specificity at PI-RADS ≥3 with a 5% margin. The secondary outcomes included insignificant prostate cancer (GG1) diagnosis, diagnostic evaluations at alternative risk thresholds, decision curve analyses (DCAs), and subgroup analyses considering reader expertise. Histopathology and ≥3 yr of follow-up were used for the reference standard. // Key findings and limitations: Sixty-two readers (45 centers and 20 countries) participated. The prevalence of csPCa was 33% (133/400); bpMRI and mpMRI showed similar AUROC values of 0.853 (95% confidence interval [CI], 0.819–0.887) and 0.859 (95% CI, 0.826–0.893), respectively, with a noninferior difference of –0.6% (95% CI, –1.2% to 0.1%, p < 0.001). At PI-RADS ≥3, bpMRI and mpMRI had sensitivities of 88.6% (95% CI, 84.8–92.3%) and 89.4% (95% CI, 85.8–93.1%), respectively, with a noninferior difference of –0.9% (95% CI, –1.7% to 0.0%, p < 0.001), and specificities of 58.6% (95% CI, 52.3–63.1%) and 57.7% (95% CI, 52.3–63.1%), respectively, with a noninferior difference of 0.9% (95% CI, 0.0–1.8%, p < 0.001). At alternative risk thresholds, mpMRI increased sensitivity at the expense of reduced specificity. DCA demonstrated the highest net benefit for an mpMRI pathway in cancer-averse scenarios, whereas a bpMRI pathway showed greater benefit for biopsy-averse scenarios. A subgroup analysis indicated limited additional benefit of DCE MRI for nonexperts. Limitations included that biopsies were conducted based on mpMRI imaging, and reading was performed in a sequential order. // Conclusions and clinical implications: It has been found that bpMRI is noninferior to mpMRI in csPCa diagnosis at AUROC, along with the sensitivity and specificity at PI-RADS ≥3, showing its value in individuals without prior csPCa findings and prostate treatment. Additional randomized prospective studies are required to investigate the generalizability of outcomes. date: 2025-02 date_type: published publisher: Elsevier BV official_url: https://doi.org/10.1016/j.eururo.2024.09.035 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 2329843 doi: 10.1016/j.eururo.2024.09.035 medium: Print-Electronic pii: S0302-2838(24)02640-X lyricists_name: Kasivisvanathan, Veerappan lyricists_id: VKASI35 actors_name: Kasivisvanathan, Veerappan actors_id: VKASI35 actors_role: owner funding_acknowledgements: R37 CA260346 [NCI NIH HHS] full_text_status: public publication: European Urology volume: 87 number: 2 pagerange: 240-250 event_location: Switzerland issn: 0302-2838 citation: Twilt, JJ; Saha, A; Bosma, JS; Van Ginneken, B; Bjartell, A; Padhani, AR; Bonekamp, D; ... the PI-CAI Consortium; + view all <#> Twilt, JJ; Saha, A; Bosma, JS; Van Ginneken, B; Bjartell, A; Padhani, AR; Bonekamp, D; Villeirs, G; Salomon, G; Giannarini, G; Kalpathy-Cramer, J; Barentsz, J; Maier-Hein, KH; Rusu, M; Rouvière, O; Van den Bergh, R; Panebianco, V; Kasivisvanathan, V; Obuchowski, NA; Yakar, D; Elschot, M; Veltman, J; Fütterer, JJ; Huisman, H; De Rooij, M; Saha, A; Bosma, JS; Van Ginneken, B; Noordman, CR; Slootweg, I; Roest, C; Fransen, SJ; Sunoqrot, MRS; Bathen, TF; Rouw, D; Geerdink, J; Van Run, C; Groeneveld, M; Meakin, J; Immerzeel, JJFM; Yakar, D; Veltman, J; Fütterer, JJ; De Rooij, M; Huisman, H; Bjartell, A; Padhani, AR; Bonekamp, D; Villeirs, G; Salomon, G; Giannarini, G; Kalpathy-Cramer, J; Barentsz, J; Maier-Hein, KH; Rusu, M; Obuchowski, NA; Rouviere, O; Van den Bergh, R; Panebianco, V; Kasivisvanathan, V; Malakoti-Fard, A; Mačiūnien, A; Kawashima, A; Gaivão, AM; Moreira, ASL; Ponsiglione, A; Rappaport, A; Stanzione, A; Ciuvasovas, A; Turkbey, B; Keyzer, BD; Pedersen, BG; Eijlers, B; Chen, C; Riccardo, C; Alis, D; Courrech Staal, EFW; Thimansson, E; Jäderling, F; Langkilde, F; Aringhieri, G; Brembilla, G; Son, H; Van der Lelij, H; Raat, HPJ; Pikūnienė, I; Macova, I; Schoots, I; Caglic, I; Zawaideh, JP; Wallström, J; Bittencourt, LK; Khurram, M; Choi, MH; Takahashi, N; Tan, N; Franco, PN; Gutierrez, PA; the PI-CAI Consortium; - view fewer <#> (2025) Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer: An International, Paired, Noninferiority, Confirmatory Observer Study. European Urology , 87 (2) pp. 240-250. 10.1016/j.eururo.2024.09.035 <https://doi.org/10.1016/j.eururo.2024.09.035>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10204691/1/Kasivisvanathan_1-s2.0-S030228382402640X-main.pdf