With the growing adoption of active surveillance (AS) clinical parameters that can tailor the intensity of monitoring are increasingly needed. Therefore, we aimed to evaluate the prognostic value of negative follow-up biopsy for reclassification and upgrading in prostate cancer (PCa) patients managed with AS.

The PubMed, Web of Science, and Scopus databases were queried to identify relevant studies published until November 2020 according to the Preferred Reporting Items for Systematic Review and Meta-analysis statement. We performed a formal meta-analysis for the reclassification and upgrading in the full cohort and selected subgroups.

We identified thirteen and nine studies eligible for the systematic review and meta-analysis, respectively. A total of 2628 patients were included in the meta-analysis. Any negative follow-up biopsy was associated with significantly lower risk of reclassification (hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.39-0.55; p <0.01), and upgrading (HR 0.54, 95% CI 0.44-0.66; p <0.01). For the confirmatory biopsy subgroup, the results remained significant for reclassification (HR 0.44, 95% CI 0.36-0.55; p <0.01) and upgrading (HR 0.55, 95% CI 0.42-0.73; p <0.01). These patterns remained robust among patients with only Gleason Grade prognostic group 1 (reclassification HR 0.47, 95% CI 0.39-0.57; p <0.01; upgrading HR 0.54, 95% CI 0.42-0.69; p <0.01).

A negative follow-up biopsy is associated with an approximately 50% decrease in the risk of future reclassification and upgrading. Incorporation of the negative follow-up biopsy into current protocols should allow for personalized AS tailoring and more precise decision-making.