Objectives <p>To evaluate whether a two-step, ‘stage-gated’ reporting approach could improve the positive predictive value (PPV) of biparametric (bp)MRI for prostate cancer (PCa) screening compared to conventional Likert/PI-RADS scoring.</p> Materials and methods <p>This retrospective secondary analysis utilised data from IP1-PROSTAGRAM—a prospective, population-based study of men aged 50–69 years who underwent PCa screening with bpMRI, ultrasound and prostate-specific antigen (PSA) testing between October 2018 and May 2019 at two centres (NCT03702439). MRI scans from IP1-PROSTAGRAM were retrospectively evaluated using the ‘stage-gated’ approach: three radiologists independently reviewed limited MRI sequences (axial T2-weighted and b1500 diffusion-weighted images) and classified scans as positive or negative; if positive, the remaining bpMRI images were reviewed and a hypothetical “decision-to-biopsy” made.</p> <p>The PPV of ‘stage-gated’ reading was compared to PI-RADS and Likert scores ≥ 4 from the original IP1-PROSTAGRAM bpMRI reports. The reference standard was IP1-PROSTAGRAM biopsy results with grade group (GG) ≥ 2 cancer considered significant.</p> Results <p>Of 408 participants (median age 57 years [IQR 53, 61]), 405 had MRI scans available for secondary analysis. The prevalence of GG ≥ 2 cancer was 4% (17/405). The ‘stage-gated’ reporting approach achieved a PPV of 53% (95% CI: 30, 75; 8/15), compared to 29% (95% CI: 15, 47; 8/28) and 30% (95% CI: 17, 46; 11/37) for Likert and PI-RADS ≥ 4 pathways, respectively. The ‘stage-gated’ approach halved the number of recommended biopsies while maintaining similar cancer detection rates.</p> Conclusion <p>The ‘stage-gated’ reporting approach, using limited sequences for the initial read, may improve the PPV and benefit-to-harm ratio of MRI-based screening.</p> Key Points <p><Emphasis Type="BoldItalic">Question</Emphasis><i> The PPV of MRI in PCa screening is low, likely because conventional assessment systems are not optimised for low disease prevalence populations</i>.</p> <p><Emphasis Type="BoldItalic">Findings</Emphasis><i> A two-step, ‘stage-gated’ reading approach achieved a PPV of 53% (8/15), compared to 29% (8/28) for Likert and 30% (11/37) for PI-RADS scores ≥ 4</i>.</p> <p><Emphasis Type="BoldItalic">Clinical relevance</Emphasis><i> The ‘stage-gated’ reporting approach, which uses limited sequences for the initial read, may improve the PPV and benefit-to-harm ratio of MRI-based screening by reducing unnecessary biopsies. Prospective evaluation is needed to confirm these findings in real-world screening settings</i>.</p> Graphical Abstract <p></p>

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Diagnostic accuracy of a ‘stage-gated’ approach for reporting prostate screening MRI: “Is less more?”

  • Natasha Thorley,
  • Tom Parry,
  • Giorgio Brembilla,
  • Francesco Giganti,
  • Tristan Barrett,
  • David Eldred-Evans,
  • Nikhil Mayor,
  • Alistair Lamb,
  • Penny L. Hubbard Cristinacce,
  • Fiona Gong,
  • Henry H. Tam,
  • Heminder K. Sokhi,
  • Anwar R. Padhani,
  • Caroline M. Moore,
  • David Atkinson,
  • Hashim U. Ahmed,
  • Shonit Punwani

摘要

Objectives

To evaluate whether a two-step, ‘stage-gated’ reporting approach could improve the positive predictive value (PPV) of biparametric (bp)MRI for prostate cancer (PCa) screening compared to conventional Likert/PI-RADS scoring.

Materials and methods

This retrospective secondary analysis utilised data from IP1-PROSTAGRAM—a prospective, population-based study of men aged 50–69 years who underwent PCa screening with bpMRI, ultrasound and prostate-specific antigen (PSA) testing between October 2018 and May 2019 at two centres (NCT03702439). MRI scans from IP1-PROSTAGRAM were retrospectively evaluated using the ‘stage-gated’ approach: three radiologists independently reviewed limited MRI sequences (axial T2-weighted and b1500 diffusion-weighted images) and classified scans as positive or negative; if positive, the remaining bpMRI images were reviewed and a hypothetical “decision-to-biopsy” made.

The PPV of ‘stage-gated’ reading was compared to PI-RADS and Likert scores ≥ 4 from the original IP1-PROSTAGRAM bpMRI reports. The reference standard was IP1-PROSTAGRAM biopsy results with grade group (GG) ≥ 2 cancer considered significant.

Results

Of 408 participants (median age 57 years [IQR 53, 61]), 405 had MRI scans available for secondary analysis. The prevalence of GG ≥ 2 cancer was 4% (17/405). The ‘stage-gated’ reporting approach achieved a PPV of 53% (95% CI: 30, 75; 8/15), compared to 29% (95% CI: 15, 47; 8/28) and 30% (95% CI: 17, 46; 11/37) for Likert and PI-RADS ≥ 4 pathways, respectively. The ‘stage-gated’ approach halved the number of recommended biopsies while maintaining similar cancer detection rates.

Conclusion

The ‘stage-gated’ reporting approach, using limited sequences for the initial read, may improve the PPV and benefit-to-harm ratio of MRI-based screening.

Key Points

Question The PPV of MRI in PCa screening is low, likely because conventional assessment systems are not optimised for low disease prevalence populations.

Findings A two-step, ‘stage-gated’ reading approach achieved a PPV of 53% (8/15), compared to 29% (8/28) for Likert and 30% (11/37) for PI-RADS scores ≥ 4.

Clinical relevance The ‘stage-gated’ reporting approach, which uses limited sequences for the initial read, may improve the PPV and benefit-to-harm ratio of MRI-based screening by reducing unnecessary biopsies. Prospective evaluation is needed to confirm these findings in real-world screening settings.

Graphical Abstract