Does a Negative Prostate Biopsy Reduce the Risk of Prostate Cancer Reclassification in an Active Surveillance Protocol? An Updated Systematic Review and Meta-Analysis.

Objectives: To evaluate the association of the negative confirmatory and follow-up biopsy with prostate cancer reclassification in active surveillance protocol.

Materials and methods: A systematic search was performed in databases, including Scopus, PubMed, Embase, and Web of Science, on June 25th, 2024, to identify relevant studies regarding negative biopsy and reclassification of prostate cancer among men on AS. The patient data including, sample sizes, follow-up duration, the status of performing the confirmatory biopsy, hazard ratio (HR), and 95% confidence intervals (CI) of each reported HR were evaluated in each study. The relationships between negative biopsies and reclassification were assessed using a forest plot. A random-effect meta-analysis was used when high heterogeneity existed among the studies. Otherwise, a fixed-effect meta-analysis was utilized. A p value of less than 0.05 was considered statistically significant. All statistical analyses were performed by using STATA statistical software, version 16.

Results: A total of 13 articles were included in the study. These articles were published between 2008 and 2023, with the majority being published in recent years (2020-2023). The included articles evaluated a total of 17,900 patients. Our results regarding reclassification and upgrading are represented according to the confirmatory biopsy and subsequent follow-up biopsies. After a negative confirmatory biopsy, the pooled HR for reclassification was 0.46 (95% CI: 0.38-0.55, p < 0.01). Secondly, the study demonstrated that a decreased chance of cancer upgrading was also connected with negative confirmatory biopsies with a pooled HR of 0.57 (95% CI: 0.45-0.72, p < 0.01). Negative follow-up biopsies were linked to a 55% decrease in the risk of reclassification, according to the pooled HR for reclassification in patients with negative biopsies compared to those with positive biopsies of 0.45 (95% CI: 0.42-0.48, p < 0.01). Also, patients with negative follow-up biopsies had a pooled HR for upgrading of 0.57 (95% CI: 0.48-0.67, p < 0.01), indicating a 43% lower chance of upgrading than in patients with positive biopsies.

Conclusion: In active surveillance of PCa patients, a negative confirmatory biopsy decreased the chance of cancer reclassification and upgrading, with the pooled OR 0.46 and 0.57 [p < 0.01], respectively. Also, negative follow-up biopsies were linked to a decreased chance of cancer reclassification and upgrading. Our review recommends extend the follow-up evaluations in PCa patients with negative findings in surveillance biopsy who scheduled for active surveillance.