Expanding Active Surveillance Inclusion Criteria: A Novel Nomogram Including Preoperative Clinical Parameters and Magnetic Resonance Imaging Findings

Abstract

Background: Current European Association of Urology, American Urological Association, and National Comprehensive Cancer Network guidelines recommend active surveillance (AS) for selected intermediate-risk prostate cancer (PCa) patients. However, limited evidence exists regarding which men can be selected safely.

Objective: To externally validate the Gandaglia risk calculator (Gandaglia-RC), designed to predict adverse pathology (AP) at radical prostatectomy (RP) and thus able to improve selection of intermediate-risk PCa patients suitable for AS, and to assess whether addition of magnetic resonance imaging (MRI) findings (MAP model) improves the predictive ability of Gandaglia-RC.

Design, setting, and participants: This is a retrospective analysis of a single-center cohort of 1284 consecutive men with low- and intermediate-risk PCa treated with RP between 2013 and 2019.

Outcome measurements and statistical analysis: AP was defined as non-organ-confined disease and/or lymph node invasion and/or pathological grade group≥3 at RP. Logistic regression was used to calculate the predictors of AP; calculated coefficients were used to develop a risk score. Receiver operating characteristic curve analysis and decision curve analysis were performed to evaluate the net benefit within models.

Results and limitations: At multivariable analysis, age at surgery, prostate-specific antigen, systematic and targeted biopsy Gleason grade group, MRI prostate volume, Prostate Imaging Reporting and Data System score, and MRI extraprostatic extension were significantly associated with AP. The model significantly improved the ability of Gandaglia-RC to predict AP (area under the curve 0.71 vs 0.63 [p<0.0001]). Using a 30% threshold, the proportions of men eligible for AS were 45% and 77% and the risks of AP were 16% and 17%, for Gandaglia-RC and MAP model, respectively.

Conclusions: Compared with Gandaglia-RC, the MAP model significantly increased the number of patients eligible for AS without significantly increasing the risk of AP at RP.

Patient summary: In this report, we have developed a risk prediction tool to select men for conservative treatment of prostate cancer. Using the novel tool, more men could safely be allocated to conservative treatment rather than surgery or radiation.

Keywords: Active surveillance; Adverse pathology; Intermediate-risk prostate cancer; Prostate cancer; Risk calculator.