Multicenter Validation of a Risk Classification Cluster for Unfavorable Pathology in Prostatectomy Specimens of Patients with an Active Surveillance Expanded Inclusion Criteria.

Background

Active surveillance (AS) criteria in prostate cancer (PCa) are expanding to include selected patients with intermediate-risk features. This multicenter retrospective study aimed to validate a proposed risk group (RG) classification for predicting unfavorable pathology (UP) in radical prostatectomy specimens among patients eligible for AS under expanded criteria.

Methods

Patients from three Andalusian university hospitals who met the AS criteria, defined as prostate-specific antigen (PSA) ≤ 20 ng/mL, International Society of Urological Pathology (ISUP) ≤ 2, and clinical stage ≤ cT2, were included. The patients were stratified into five RGs according to PSA density, Prostate Imaging Reporting and Data System score (PI-RADS), and clinical stage. UP was defined as ≥pT3a and/or pN+ and/or ISUP grade ≥ 3.

Results

A total of 244 patients were analyzed. The median age was 63 years, the median PSA 5.98 ng/mL, and the median PSA density was 0.14 ng/cc. UP was identified in 47.1% of radical prostatectomy specimens, increasing progressively across RGs from 20.8% to 93.3%. Each incremental RG was associated with a higher risk of UP, with an odds ratio of 2.14 and moderate predictive accuracy, as reflected by an area under the curve of 0.70.

Conclusions

The proposed RG classification showed moderate predictive capacity for UP and may improve risk stratification in intermediate-risk patients considered for AS.