1. Clinical validation of the iXip index in avoiding unnecessary prostate biopsy: Results from a prospective multicenter study involving 426 patients
- Author
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Gianluca Giannarini, Danilo Zani, Lucio Laurini, A. Garbeglio, Filiberto Zattoni, Mario Plebani, Andrea Gallotta, Giorgio Fassina, and S. Guazzieri
- Subjects
Oncology ,PCA3 ,Cancer Research ,medicine.medical_specialty ,Prostate biopsy ,030232 urology & nephrology ,prostatic neoplasm ,PSA ,03 medical and health sciences ,Prostate cancer ,0302 clinical medicine ,Prostate ,Internal medicine ,Biopsy ,Medicine ,prostate biopsy ,Prostate Health Index ,Prostate CAncer Gene 3 ,medicine.diagnostic_test ,business.industry ,PSA-IgM ,Cancer ,biomarker ,diagnostic accuracy ,iXip ,medicine.disease ,medicine.anatomical_structure ,Multicenter study ,030220 oncology & carcinogenesis ,Biomarker (medicine) ,business - Abstract
Purpose To assess the diagnostic accuracy of iXip, a novel biomarker for prostate cancer detection at initial biopsy based on an algorithm including patient age, prostate volume, PSA and PSA-IgM levels,. Materials and methods This was a prospective multicenter study involving 426 consecutive men undergoing initial prostate biopsy with at least 12 cores in a real-life clinical setting. Diagnostic accuracy of iXip for prostate cancer detection was calculated with AUC and compared to that of prostate volume, PSA and PSA-IgM levels. The correlation of iXip with tumor aggressiveness, defined as any cancer with Gleason score ≥7, was evaluated by Spearman ρ coefficient analysis. Results Prostate cancer was diagnosed in 193/426 patients (45%), of which 65 (35%) had Gleason score ≥7. iXip values were significantly higher in patients with cancer than in those without cancer (median value 55% vs. 39%, p Conclusions Our prospective multicenter study suggests that the novel biomarker iXip may be used with a 20% cut-off value in order to reduce the proportion of prostate biopsies by approximately 5%, without missing a single case of cancer. Moreover, higher iXip values are significantly correlated with tumor aggressiveness.
- Published
- 2017