Avoiding Unnecessary Biopsy after Multiparametric Prostate MRI with VERDICT Analysis: The INNOVATE Study.

Background In men suspected of having prostate cancer (PCa), up to 50% of men with positive multiparametric MRI (mpMRI) findings (Prostate Imaging Reporting and Data System [PI-RADS] or Likert score of 3 or higher) have no clinically significant (Gleason score ≤3+3, benign) biopsy findings. Vascular, Extracellular, and Restricted Diffusion for Cytometry in Tumor (VERDICT) MRI analysis could improve the stratification of positive mpMRI findings. Purpose To evaluate VERDICT MRI, mpMRI-derived apparent diffusion coefficient (ADC), and prostate-specific antigen density (PSAD) as determinants of clinically significant PCa (csPCa). Materials and Methods Between April 2016 and December 2019, men suspected of having PCa were prospectively recruited from two centers and underwent VERDICT MRI and mpMRI at one center before undergoing targeted biopsy. Biopsied lesion ADC, lesion-derived fractional intracellular volume (FIC), and PSAD were compared between men with csPCa and those without csPCa, using nonparametric tests subdivided by Likert scores. Area under the receiver operating characteristic curve (AUC) was calculated to test diagnostic performance. Results Among 303 biopsy-naive men, 165 study participants (mean age, 65 years ± 7 [SD]) underwent targeted biopsy; of these, 73 had csPCa. Median lesion FIC was higher in men with csPCa (FIC, 0.53) than in those without csPCa (FIC, 0.18) for Likert 3 (P = .002) and Likert 4 (0.60 vs 0.28, P < .001) lesions. Median lesion ADC was lower for Likert 4 lesions with csPCa (0.86 × 10-3 mm2/sec) compared with lesions without csPCa (1.12 × 10-3 mm2/sec, P = .03), but there was no evidence of a difference for Likert 3 lesions (0.97 × 10-3 mm2/sec vs 1.20 × 10-3 mm2/sec, P = .09). PSAD also showed no difference for Likert 3 (0.17 ng/mL2 vs 0.12 ng/mL2, P = .07) or Likert 4 (0.14 ng/mL2 vs 0.12 ng/mL2, P = .47) lesions. The diagnostic performance of FIC (AUC, 0.96; 95% CI: 0.93, 1.00) was higher (P = .02) than that of ADC (AUC, 0.85; 95% CI: 0.79, 0.91) and PSAD (AUC, 0.74; 95% CI: 0.66, 0.82) for the presence of csPCa in biopsied lesions. Conclusion Lesion fractional intracellular volume enabled better classification of clinically significant prostate cancer than did apparent diffusion coefficient and prostate-specific antigen density. Clinical trial registration no. NCT02689271 © RSNA, 2022 Online supplemental material is available for this article.

Radiology. 2022 Aug 02 [Epub ahead of print]

Saurabh Singh, Harriet Rogers, Baris Kanber, Joey Clemente, Hayley Pye, Edward W Johnston, Tom Parry, Alistair Grey, Eoin Dinneen, Greg Shaw, Susan Heavey, Urszula Stopka-Farooqui, Aiman Haider, Alex Freeman, Francesco Giganti, David Atkinson, Caroline M Moore, Hayley C Whitaker, Daniel C Alexander, Eleftheria Panagiotaki, Shonit Punwani

From the Centre for Medical Imaging, Division of Medicine (S.S., H.R., J.C., E.W.J., T.P., D.A., S.P.), Centre for Medical Image Computing, Department of Medical Physics and Biomedical Engineering (B.K.), Molecular Diagnostics and Therapeutics Group (H.P., S.H., U.S.F., H.C.W.), Division of Surgery and Interventional Sciences (F.G., C.M.M.), and Centre for Medical Image Computing, Department of Computer Science (D.C.A., E.P.), University College London, Charles Bell House, 43-45 Foley St, London W1W 7TS, England; Department of Diagnostic Radiology, Royal Marsden Hospital, London, England (E.W.J.); Departments of Urology (A.G., E.D., G.S., C.M.M.), Pathology (A.H., A.F.), and Radiology (F.G.), University College London Hospitals NHS Foundation Trust, London, England; and Department of Urology, Barts Health, NHS Foundation Trust, London, England (A.G., G.S.).

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