A meta-analysis on overall survival and safety outcomes in patients with nonmetastatic castration-resistant prostate cancer treated with novel hormonal agents

Several novel androgen receptor (AR)-inhibitors have been introduced for nonmetastatic castration-resistant prostate cancer (nmCRPC) treatment, with the improvement of survival outcomes which need to be balanced against the risk of adverse events. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating enzalutamide, apalutamide and darolutamide in nmCRPC patients, to assess overall survival (OS), incidence and risk of adverse drug events, adverse-events-related death and adverse-events-related treatment discontinuation. We selected three RCTs (SPARTAN, PROSPER and ARAMIS). New hormonal agents administration resulted in better OS, despite the increased risk of several any grade and grade 3-4 adverse events. In the decision-making process, careful evaluation of expected adverse events, patients' comorbidities and maintenance of quality of life are mandatory.

Automated summary

This study reviewed the use of several novel AR inhibitors in patients with nmCRPC and evaluated the overall survival, incidence and risk of adverse events, adverse-events-related death, and adverse-events-related treatment discontinuation. The use of new hormonal agents improved overall survival despite the increased risk of adverse events. Therefore, careful consideration of the expected adverse events, patients' comorbidities, and maintenance of quality of life is necessary in the decision-making process.