What question did this study set out to answer?

The study aims to create and validate a predictive model for distinguishing between insignificant and significant prostate cancer in men with tPSA in the grey zone.

April 30, 2026

Risk Stratification of Suspected Clinically LocalizedProstate Cancer Using Multi-Indicator FunctionalDifferentiation: A Predictive Model With fPSA/tPSA,PHI, PCA3, and MRI

Puntos clave

The study aims to create and validate a predictive model for distinguishing between insignificant and significant prostate cancer in men with tPSA in the grey zone.
Analyzed 242 patients with suspected localized prostate cancer who underwent biopsy.
Stratified patients into low-risk and high-risk groups based on biopsy results.
Measured biomarkers including fPSA/tPSA ratio, PHI, PCA3 scores, and assessed mp-MRI findings.
High-risk group showed significantly lower %fPSA and prostate volume, but higher PHI and PCA3 scores, all p < 0.05.
Identified %fPSA, PHI, PCA3 score, prostate volume, and PI-RADS score ≥ 4 as independent predictors.
Nomogram demonstrated excellent discrimination with AUC of 0.885, validated with AUC of 0.863 in an independent cohort.

Resumen

Background: Accurate risk stratification is crucial for managing men with suspected clinically localized prostate cancer, particularly those with total prostate-specific antigen (tPSA) in the diagnostic grey zone (4–10 ng/mL). This study aimed to develop and validate a predictive model integrating multi-dimensional indicators to distinguish clinically insignificant prostate cancer from significant disease. Methods: This retrospective cohort study analysed 242 patients with suspected clinically localized prostate cancer who underwent biopsy from January 2020–December 2021. Patients were stratified into low-risk (n = 118) and high-risk (n = 124) groups based on biopsy pathology. Key biomarkers including free prostate-specific antigen (fPSA)/tPSA ratio, Prostate Health Index (PHI), and Prostate Cancer Antigen 3 (PCA3) score were measured before biopsy. Multiparametric magnetic resonance imaging (mp-MRI) parameters were also assessed. Results: The high-risk group had significantly lower percentage of free to total prostate‑specific antigen (%fPSA) and prostate volume, but higher PHI, PCA3 scores, and positive Prostate Imaging-Reporting and Data System (PI-RADS) findings (all p Conclusions: The developed nomogram, integrating initial fPSA/tPSA screening, PHI risk quantification, PCA3 molecular confirmation, and magnetic resonance imaging (MRI) features, provides an effective tool for personalized risk stratification, with direct comparative analyses confirming its advantage over single-modality approaches.

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