Accurate diagnosis of prostate cancer by combining Proclarix with magnetic resonance imaging.

Autor: Morote J; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Pye H; Molecular Diagnostics and Therapeutics Group, University College London, London, UK., Campistol M; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Celma A; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Regis L; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Semidey M; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., de Torres I; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Mast R; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Planas J; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Santamaria A; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Trilla E; Vall d'Hebron Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Athanasiou A; Proteomedix AG, Zürich, Switzerland., Singh S; Molecular Diagnostics and Therapeutics Group, University College London, London, UK., Heavey S; Molecular Diagnostics and Therapeutics Group, University College London, London, UK., Stopka-Farooqui U; Molecular Diagnostics and Therapeutics Group, University College London, London, UK., Freeman A; Molecular Diagnostics and Therapeutics Group, University College London, London, UK., Haider A; Molecular Diagnostics and Therapeutics Group, University College London, London, UK., Schiess R; Proteomedix AG, Zürich, Switzerland., Whitaker HC; Molecular Diagnostics and Therapeutics Group, University College London, London, UK., Punwani S; Centre for Medical Imaging, University College London, London, UK., Ahmed HU; Imperial Prostate, Department of Surgery and Cancer, Imperial College London, London, UK.; Imperial Urology, Imperial College Healthcare NHS Trust, London, UK., Emberton M; Division of Surgery and Interventional Science, University College London, London, UK.
Jazyk: angličtina
Zdroj: BJU international [BJU Int] 2023 Aug; Vol. 132 (2), pp. 188-195. Date of Electronic Publication: 2023 Mar 21.
DOI: 10.1111/bju.15998
Abstrakt: Objectives: To assess of the clinical performance of Proclarix ® (a novel Conformité Européenne [CE]-marked biomarker test aiding in the identification of clinically significant prostate cancer [csPCa]) alone or in combination with multiparametric magnetic resonance imaging (mpMRI) to predict csPCa (International Society of Urological Pathology Grade Group ≥2).
Patients and Methods: The study included blood samples from 721 men undergoing mpMRI followed by biopsy at University College London, London, and Vall d'Hebron University Hospital, Barcelona. Samples were tested blindly. The Proclarix-MRI model combining prostate volume, Proclarix and mpMRI results was trained using the UCL cohort (n = 159) and validated in the Vall d'Hebron cohort (n = 562). Its diagnostic performance was established in correlation to biopsy outcome and compared to available clinical parameters and risk calculators.
Results: Clinical performance of the Proclarix-MRI model in the validation cohort did not significantly differ from the training cohort and resulted in a sensitivity for csPCa of 90%, 90% negative predictive value and 66% positive predictive value. The Proclarix-MRI score's specificity (68%) was significantly (P < 0.001) better than the MRI-European Randomized study of Screening for Prostate Cancer risk score (51%), Proclarix (27%) or mpMRI (28%) alone. In addition, Proclarix by itself was found to be useful in the MRI Prostate Imaging-Reporting and Data System (PI-RADS) score 3 subgroup by outperforming prostate-specific antigen density in terms of specificity (25% vs 13%, P = 0.004) at 100% sensitivity.
Conclusion: When combined with mpMRI and prostate volume, Proclarix reliably predicted csPCa and ruled out men with no or indolent cancer. A large reduction of two thirds of unneeded biopsies was achieved. Proclarix can further be used with high confidence to reliably detect csPCa in men with an indeterminate PI-RADS score 3 mpMRI. Despite these encouraging results, further validation is needed.
(© 2023 BJU International.)
Databáze: MEDLINE
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