Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer: An International, Paired, Noninferiority, Confirmatory Observer Study

Jasper J. Twilt; Anindo Saha; Joeran S. Bosma; Bram van Ginneken; Anders Bjartell; Anwar R. Padhani; David Bonekamp; Geert Villeirs; Georg Salomon; Gianluca Giannarini; Jayashree Kalpathy-Cramer; Jelle Barentsz; Klaus H. Maier-Hein; Mirabela Rusu; Olivier Rouvière; Roderick van den Bergh; Valeria Panebianco; Veeru Kasivisvanathan; Nancy A. Obuchowski; Derya Yakar; Mattijs Elschot; Jeroen Veltman; Jurgen J. Fütterer; Henkjan Huisman; Maarten de Rooij; Jasper J. Twilt; Anindo Saha; Joeran S. Bosma; Bram van Ginneken; Constant R. Noordman; Ivan Slootweg; Christian Roest; Stefan J. Fransen; Mohammed R.S. Sunoqrot; Tone F. Bathen; Dennis Rouw; Jeroen Geerdink; Chris van Run; Miriam Groeneveld; James Meakin; Jos J.F.M. Immerzeel; Derya Yakar; Mattijs Elschot; Jeroen Veltman; Jurgen J. Fütterer; Maarten de Rooij; Henkjan Huisman; Anders Bjartell; Anwar R. Padhani; David Bonekamp; Geert Villeirs; Georg Salomon; Gianluca Giannarini; Jayashree Kalpathy-Cramer; Jelle Barentsz; Klaus H. Maier-Hein; Mirabela Rusu; Nancy A. Obuchowski; Olivier Rouviere; Roderick van den Bergh; Valeria Panebianco; Veeru Kasivisvanathan; Afsoun Malakoti-Fard; Agnė Mačiūnien; Akira Kawashima; Ana M. Gaivão; Ana S.L. Moreira; Andrea Ponsiglione; Annelies Rappaport; Arnaldo Stanzione; Arturas Ciuvasovas; Baris Turkbey; Bart De Keyzer; Bodil G. Pedersen; Bram Eijlers; Christine Chen; Ciabattoni Riccardo; Deniz Alis; Ewout F.W. Courrech Staal; Erik Thimansson; Fredrik Jäderling; Fredrik Langkilde; Giacomo Aringhieri; Giorgio Brembilla; Hannah Son; Hans van der Lelij; Henricus P.J. Raat; Ingrida Pikūnienė; Iva Macova; Ivo Schoots; Iztok Caglic; Jeries P. Zawaideh; Jonas Wallström; Leonardo K. Bittencourt; Misbah Khurram; Moon Hyung Choi; Naoki Takahashi; Nelly Tan; Paolo N. Franco; Patricia A. Gutierrez; Petr Hanus; Philippe Puech; Philipp R. Rau; Pieter de Visschere; Ramette Guillaume; Renato Cuocolo; Ricardo O. Falcão; Rogier S.A. van Stiphout; Rossano Girometti; Ruta Briediene; Rūta Grigienė; Samuel Gitau; Samuel Withey; Sangeet Ghai; Tobias Penzkofer; Tristan Barrett; Varaha Sai Tammisetti; Vibeke B. Løgager; Vladimír Černý; Wulphert Venderink; Yan Mee Law; Young Joon Lee

doi:10.1016/j.eururo.2024.09.035

Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer: An International, Paired, Noninferiority, Confirmatory Observer Study

Jasper J. Twilt^*, Anindo Saha, Joeran S. Bosma, Bram van Ginneken, Anders Bjartell, Anwar R. Padhani, David Bonekamp, Geert Villeirs, Georg Salomon, Gianluca Giannarini, Jayashree Kalpathy-Cramer, Jelle Barentsz, Klaus H. Maier-Hein, Mirabela Rusu, Olivier Rouvière, Roderick van den Bergh, Valeria Panebianco, Veeru Kasivisvanathan, Nancy A. Obuchowski, Derya YakarMattijs Elschot, Jeroen Veltman, Jurgen J. Fütterer, Henkjan Huisman, Maarten de Rooij, Jasper J. Twilt^*, Anindo Saha, Joeran S. Bosma, Bram van Ginneken, Constant R. Noordman, Ivan Slootweg, Christian Roest, Stefan J. Fransen, Mohammed R.S. Sunoqrot, Tone F. Bathen, Dennis Rouw, Jeroen Geerdink, Chris van Run, Miriam Groeneveld, James Meakin, Jos J.F.M. Immerzeel, Derya Yakar, Mattijs Elschot, Jeroen Veltman, Jurgen J. Fütterer, Maarten de Rooij, Henkjan Huisman, Anders Bjartell, Anwar R. Padhani, David Bonekamp, Geert Villeirs, Georg Salomon, Gianluca Giannarini, Jayashree Kalpathy-Cramer, Jelle Barentsz, Klaus H. Maier-Hein, Mirabela Rusu, Nancy A. Obuchowski, Olivier Rouviere, Roderick van den Bergh, Valeria Panebianco, Veeru Kasivisvanathan, Afsoun Malakoti-Fard, Agnė Mačiūnien, Akira Kawashima, Ana M. Gaivão, Ana S.L. Moreira, Andrea Ponsiglione, Annelies Rappaport, Arnaldo Stanzione, Arturas Ciuvasovas, Baris Turkbey, Bart De Keyzer, Bodil G. Pedersen, Bram Eijlers, Christine Chen, Ciabattoni Riccardo, Deniz Alis, Ewout F.W. Courrech Staal, Erik Thimansson, Fredrik Jäderling, Fredrik Langkilde, Giacomo Aringhieri, Giorgio Brembilla, Hannah Son, Hans van der Lelij, Henricus P.J. Raat, Ingrida Pikūnienė, Iva Macova, Ivo Schoots, Iztok Caglic, Jeries P. Zawaideh, Jonas Wallström, Leonardo K. Bittencourt, Misbah Khurram, Moon Hyung Choi, Naoki Takahashi, Nelly Tan, Paolo N. Franco, Patricia A. Gutierrez, Petr Hanus, Philippe Puech, Philipp R. Rau, Pieter de Visschere, Ramette Guillaume, Renato Cuocolo, Ricardo O. Falcão, Rogier S.A. van Stiphout, Rossano Girometti, Ruta Briediene, Rūta Grigienė, Samuel Gitau, Samuel Withey, Sangeet Ghai, Tobias Penzkofer, Tristan Barrett, Varaha Sai Tammisetti, Vibeke B. Løgager, Vladimír Černý, Wulphert Venderink, Yan Mee Law, Young Joon Lee

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

4 Citations (Scopus)

5 Downloads (Pure)

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.

Original language	English
Pages (from-to)	240-250
Number of pages	11
Journal	European Urology
Volume	87
Issue number	2
DOIs	https://doi.org/10.1016/j.eururo.2024.09.035
Publication status	Published - Feb 2025

Bibliographical note

Publisher Copyright:
© 2024 The Authors

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Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate CancerFinal published version, 1.15 MBLicence: CC BY

Cite this

Twilt, J. J., Saha, A., Bosma, J. S., van Ginneken, B., Bjartell, A., Padhani, A. R., Bonekamp, D., Villeirs, G., Salomon, G., Giannarini, G., Kalpathy-Cramer, J., Barentsz, J., Maier-Hein, K. H., Rusu, M., Rouvière, O., van den Bergh, R., Panebianco, V., Kasivisvanathan, V., Obuchowski, N. A., ... Lee, Y. J. (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), 240-250. https://doi.org/10.1016/j.eururo.2024.09.035

@article{d9531e5527a54b29bea1e784f06eab97,

title = "Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer: An International, Paired, Noninferiority, Confirmatory Observer Study",

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.",

author = "Twilt, {Jasper J.} and Anindo Saha and Bosma, {Joeran S.} and {van Ginneken}, Bram and Anders Bjartell and Padhani, {Anwar R.} and David Bonekamp and Geert Villeirs and Georg Salomon and Gianluca Giannarini and Jayashree Kalpathy-Cramer and Jelle Barentsz and Maier-Hein, {Klaus H.} and Mirabela Rusu and Olivier Rouvi{\`e}re and {van den Bergh}, Roderick and Valeria Panebianco and Veeru Kasivisvanathan and Obuchowski, {Nancy A.} and Derya Yakar and Mattijs Elschot and Jeroen Veltman and F{\"u}tterer, {Jurgen J.} and Henkjan Huisman and {de Rooij}, Maarten and Twilt, {Jasper J.} and Anindo Saha and Bosma, {Joeran S.} and {van Ginneken}, Bram and Noordman, {Constant R.} and Ivan Slootweg and Christian Roest and Fransen, {Stefan J.} and Sunoqrot, {Mohammed R.S.} and Bathen, {Tone F.} and Dennis Rouw and Jeroen Geerdink and {van Run}, Chris and Miriam Groeneveld and James Meakin and Immerzeel, {Jos J.F.M.} and Derya Yakar and Mattijs Elschot and Jeroen Veltman and F{\"u}tterer, {Jurgen J.} and {de Rooij}, Maarten and Henkjan Huisman and Anders Bjartell and Padhani, {Anwar R.} and David Bonekamp and Geert Villeirs and Georg Salomon and Gianluca Giannarini and Jayashree Kalpathy-Cramer and Jelle Barentsz and Maier-Hein, {Klaus H.} and Mirabela Rusu and Obuchowski, {Nancy A.} and Olivier Rouviere and {van den Bergh}, Roderick and Valeria Panebianco and Veeru Kasivisvanathan and Afsoun Malakoti-Fard and Agnė Ma{\v c}iūnien and Akira Kawashima and Gaiv{\~a}o, {Ana M.} and Moreira, {Ana S.L.} and Andrea Ponsiglione and Annelies Rappaport and Arnaldo Stanzione and Arturas Ciuvasovas and Baris Turkbey and Keyzer, {Bart De} and Pedersen, {Bodil G.} and Bram Eijlers and Christine Chen and Ciabattoni Riccardo and Deniz Alis and {Courrech Staal}, {Ewout F.W.} and Erik Thimansson and Fredrik J{\"a}derling and Fredrik Langkilde and Giacomo Aringhieri and Giorgio Brembilla and Hannah Son and {van der Lelij}, Hans and Raat, {Henricus P.J.} and Ingrida Pikūnienė and Iva Macova and Ivo Schoots and Iztok Caglic and Zawaideh, {Jeries P.} and Jonas Wallstr{\"o}m and Bittencourt, {Leonardo K.} and Misbah Khurram and Choi, {Moon Hyung} and Naoki Takahashi and Nelly Tan and Franco, {Paolo N.} and Gutierrez, {Patricia A.} and Petr Hanus and Philippe Puech and Rau, {Philipp R.} and {de Visschere}, Pieter and Ramette Guillaume and Renato Cuocolo and Falc{\~a}o, {Ricardo O.} and {van Stiphout}, {Rogier S.A.} and Rossano Girometti and Ruta Briediene and Rūta Grigienė and Samuel Gitau and Samuel Withey and Sangeet Ghai and Tobias Penzkofer and Tristan Barrett and Tammisetti, {Varaha Sai} and L{\o}gager, {Vibeke B.} and Vladim{\'i}r {\v C}ern{\'y} and Wulphert Venderink and Law, {Yan Mee} and Lee, {Young Joon}",

note = "Publisher Copyright: {\textcopyright} 2024 The Authors",

year = "2025",

month = feb,

doi = "10.1016/j.eururo.2024.09.035",

language = "English",

volume = "87",

pages = "240--250",

journal = "European Urology",

issn = "0302-2838",

publisher = "Elsevier",

number = "2",

}

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, Twilt, JJ, 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, Elschot, M, 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, Hanus, P, Puech, P, Rau, PR, de Visschere, P, Guillaume, R, Cuocolo, R, Falcão, RO, van Stiphout, RSA, Girometti, R, Briediene, R, Grigienė, R, Gitau, S, Withey, S, Ghai, S, Penzkofer, T, Barrett, T, Tammisetti, VS, Løgager, VB, Černý, V, Venderink, W, Law, YM & Lee, YJ 2025, 'Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer: An International, Paired, Noninferiority, Confirmatory Observer Study', European Urology, vol. 87, no. 2, pp. 240-250. https://doi.org/10.1016/j.eururo.2024.09.035

Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer: An International, Paired, Noninferiority, Confirmatory Observer Study. / Twilt, Jasper J.; Saha, Anindo; Bosma, Joeran S. et al.
In: European Urology, Vol. 87, No. 2, 02.2025, p. 240-250.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer

T2 - An International, Paired, Noninferiority, Confirmatory Observer Study

AU - Twilt, Jasper J.

AU - Saha, Anindo

AU - Bosma, Joeran S.

AU - van Ginneken, Bram

AU - Bjartell, Anders

AU - Padhani, Anwar R.

AU - Bonekamp, David

AU - Villeirs, Geert

AU - Salomon, Georg

AU - Giannarini, Gianluca

AU - Kalpathy-Cramer, Jayashree

AU - Barentsz, Jelle

AU - Maier-Hein, Klaus H.

AU - Rusu, Mirabela

AU - Rouvière, Olivier

AU - van den Bergh, Roderick

AU - Panebianco, Valeria

AU - Kasivisvanathan, Veeru

AU - Obuchowski, Nancy A.

AU - Yakar, Derya

AU - Elschot, Mattijs

AU - Veltman, Jeroen

AU - Fütterer, Jurgen J.

AU - Huisman, Henkjan

AU - de Rooij, Maarten

AU - Twilt, Jasper J.

AU - Saha, Anindo

AU - Bosma, Joeran S.

AU - van Ginneken, Bram

AU - Noordman, Constant R.

AU - Slootweg, Ivan

AU - Roest, Christian

AU - Fransen, Stefan J.

AU - Sunoqrot, Mohammed R.S.

AU - Bathen, Tone F.

AU - Rouw, Dennis

AU - Geerdink, Jeroen

AU - van Run, Chris

AU - Groeneveld, Miriam

AU - Meakin, James

AU - Immerzeel, Jos J.F.M.

AU - Yakar, Derya

AU - Elschot, Mattijs

AU - Veltman, Jeroen

AU - Fütterer, Jurgen J.

AU - de Rooij, Maarten

AU - Huisman, Henkjan

AU - Bjartell, Anders

AU - Padhani, Anwar R.

AU - Bonekamp, David

AU - Villeirs, Geert

AU - Salomon, Georg

AU - Giannarini, Gianluca

AU - Kalpathy-Cramer, Jayashree

AU - Barentsz, Jelle

AU - Maier-Hein, Klaus H.

AU - Rusu, Mirabela

AU - Obuchowski, Nancy A.

AU - Rouviere, Olivier

AU - van den Bergh, Roderick

AU - Panebianco, Valeria

AU - Kasivisvanathan, Veeru

AU - Malakoti-Fard, Afsoun

AU - Mačiūnien, Agnė

AU - Kawashima, Akira

AU - Gaivão, Ana M.

AU - Moreira, Ana S.L.

AU - Ponsiglione, Andrea

AU - Rappaport, Annelies

AU - Stanzione, Arnaldo

AU - Ciuvasovas, Arturas

AU - Turkbey, Baris

AU - Keyzer, Bart De

AU - Pedersen, Bodil G.

AU - Eijlers, Bram

AU - Chen, Christine

AU - Riccardo, Ciabattoni

AU - Alis, Deniz

AU - Courrech Staal, Ewout F.W.

AU - Thimansson, Erik

AU - Jäderling, Fredrik

AU - Langkilde, Fredrik

AU - Aringhieri, Giacomo

AU - Brembilla, Giorgio

AU - Son, Hannah

AU - van der Lelij, Hans

AU - Raat, Henricus P.J.

AU - Pikūnienė, Ingrida

AU - Macova, Iva

AU - Schoots, Ivo

AU - Caglic, Iztok

AU - Zawaideh, Jeries P.

AU - Wallström, Jonas

AU - Bittencourt, Leonardo K.

AU - Khurram, Misbah

AU - Choi, Moon Hyung

AU - Takahashi, Naoki

AU - Tan, Nelly

AU - Franco, Paolo N.

AU - Gutierrez, Patricia A.

AU - Hanus, Petr

AU - Puech, Philippe

AU - Rau, Philipp R.

AU - de Visschere, Pieter

AU - Guillaume, Ramette

AU - Cuocolo, Renato

AU - Falcão, Ricardo O.

AU - van Stiphout, Rogier S.A.

AU - Girometti, Rossano

AU - Briediene, Ruta

AU - Grigienė, Rūta

AU - Gitau, Samuel

AU - Withey, Samuel

AU - Ghai, Sangeet

AU - Penzkofer, Tobias

AU - Barrett, Tristan

AU - Tammisetti, Varaha Sai

AU - Løgager, Vibeke B.

AU - Černý, Vladimír

AU - Venderink, Wulphert

AU - Law, Yan Mee

AU - Lee, Young Joon

PY - 2025/2

Y1 - 2025/2

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85207148835&partnerID=8YFLogxK

U2 - 10.1016/j.eururo.2024.09.035

DO - 10.1016/j.eururo.2024.09.035

M3 - Article

C2 - 39438187

AN - SCOPUS:85207148835

SN - 0302-2838

VL - 87

SP - 240

EP - 250

JO - European Urology

JF - European Urology

IS - 2

ER -

Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer: An International, Paired, Noninferiority, Confirmatory Observer Study

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