Predictors of Transition to Watchful Waiting from Active Surveillance Among men with low-Risk Prostate Cancer (FIVO Cohort)

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Active Surveillance (AS) is a commonly accepted treatment approach for men with low-risk Prostate Cancer (PC). As life-expectancy shortens, men on AS protocols are slowly transitioned to Watchful Waiting (WW) protocols. Due to the diversity on AS protocols and their strict definitions, little is known about the percent of patients switching to WW and their predictors of change. Objective: To report on percent of change from AS to WW protocols and to identify predictors of transition at AS initiation.


A prospectively mantained comprehensive prostate cancer database was utilized for the analysis. A total of 3342 patients with PC were included in the database. 773 (23%) belong to the low risk PC and 1107 (33%) to the intermediate risk PC group as per NCCN guidelines. The AS protocol was initiated at our institution on 2010. Briefly, all patients included on AS undergo a transperineal 30 core prostate biopsy and mpMRI prostate (since 2014). The criteria for transition was age ?80yo and/or ADT initiation without evidence of metastatic disease (46). Binary logistic regression for transition to WW were estimated.


A total of 449 patients were included on AS. 46 (10%) patients were transitioned to WW during their follow-up. Briefly, Median age at diagnosis was 74.71 yo (IQR 72.17-76.75), median Charlson score was 3.6 (IQR 3.2-4.6), PSA at diagnosis 6.93 ng/mL (IQR 5.2-11.4). All patients were cT1. 42 (91.3%) were diagnosed with Gleason 6 score and 4 (8.7%) were diagnosed with Gleason 7 (3+4). Median PSAD was 0.17 (IQR 0.13-0.29). Median follow up in this cohort was 85.08 mo (IQR 60.7-125.8). Overall, men with low risk PC remained on AS for median of 3.46 years (IQR 2.25-5.33). A total of 15 patients died during follow up, all of them due to other causes. We identified negative confirmatory prostate biopsy (OR 0.183 (IC95%:0.086-0.301) p 0.15 at diagnosis (OR 2.3 (IC95%:1.25 -4.5) p =0.008) as predictors of transition to WW in our AS cohort. Age at diagnosis, PSA at diagnosis, Gleason score at diagnostic (initial) prostate biopsy and cT were not significative at univariate analysis.


Changes from AS to WW become common among elderly men with low-risk PC. This potential change to WW should be discussed with men starting on AS. Moreover, negative confirmatory prostate biopsy is predictive of transition to WW within this cohort.

Funding: None