Clinical validation of the iXip index in avoiding unnecessary prostate biopsy: Results from a prospective multicenter study involving 426 patients

Autor: Gianluca Giannarini, Danilo Zani, Lucio Laurini, A. Garbeglio, Filiberto Zattoni, Mario Plebani, Andrea Gallotta, Giorgio Fassina, S. Guazzieri
Rok vydání: 2017
Předmět:
Zdroj: Cancer Treatment and Research Communications. 10:40-45
ISSN: 2468-2942
Popis: 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.
Databáze: OpenAIRE