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Evaluating Biparametric Versus Multiparametric Magnetic Resonance Imaging for Diagnosing Clinically Significant Prostate Cancer: An International, Paired, Noninferiority, Confirmatory Observer Study
JJ. Twilt, A. Saha, JS. Bosma, B. van Ginneken, A. Bjartell, AR. Padhani, D. Bonekamp, G. Villeirs, G. Salomon, G. Giannarini, J. Kalpathy-Cramer, J. Barentsz, KH. Maier-Hein, M. Rusu, O. Rouvière, R. van den Bergh, V. Panebianco, V....
Language English Country Switzerland
Document type Journal Article, Multicenter Study, Comparative Study
Grant support
R37 CA260346
NCI NIH HHS - United States
- MeSH
- Middle Aged MeSH
- Humans MeSH
- Magnetic Resonance Imaging MeSH
- Multiparametric Magnetic Resonance Imaging * MeSH
- Prostatic Neoplasms * diagnostic imaging pathology MeSH
- Observer Variation MeSH
- Aged MeSH
- Neoplasm Grading MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Comparative Study MeSH
- Geographicals
- Europe MeSH
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.
Department of Diagnostic Radiology Cleveland Clinic Foundation Cleveland OH USA
Department of Diagnostic Sciences Ghent University Hospital Ghent Belgium
Department of Medical Imaging Andros Clinics Amsterdam The Netherlands
Department of Medical Imaging Radboud University Medical Center Nijmegen The Netherlands
Department of Quantitative Health Sciences Cleveland Clinic Foundation Cleveland OH USA
Department of Radiological Sciences Oncology and Pathology Sapienza University of Rome Rome Italy
Department of Radiology Netherlands Cancer Institute Amsterdam The Netherlands
Department of Radiology University Medical Center Groningen Groningen The Netherlands
Department of Radiology Ziekenhuisgroep Twente Almelo The Netherland
Department of Urology Erasmus Medical Center Rotterdam The Netherlands
Department of Urology Skåne University Hospital Lund Sweden
Departments of Radiology Urology and Biomedical Data Science Stanford University Stanford CA USA
Division of Artificial Medical Intelligence in Ophthalmology University of Colorado Boulder CO USA
Division of Medical Image Computing Deutsches Krebsforschungszentrum Heidelberg Germany
Division of Radiology Deutsches Krebsforschungszentrum Heidelberg Germany
Division of Translational Cancer Research Lund University Cancer Centre Lund Sweden
Faculté de Médecine Lyon Est Université Lyon 1 Université de Lyon Lyon France
Martini Clinic Prostate Cancer Center University Medical Centre Hamburg Eppendorf Hamburg Germany
Paul Strickland Scanner Centre Mount Vernon Cancer Centre Northwood UK
Urology Unit Santa Maria della Misericordia University Hospital Udine Italy
References provided by Crossref.org
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