OBJECTIVES: This study aims to evaluate the clinical significance of Darolutamide in the management of metastatic hormone-sensitive prostate cancer (mHSPC) through a systematic literature review.

METHODS: A systematic literature review (SLR) was conducted by searching Embase, Medline and Cochrane from database inception to June 2, 2023. Following the appropriate search strategy, an initial search yielded 57 relevant literature reviews and systematic reviews. Additionally, duplicate publications were removed, and the titles and abstracts of the remaining literature were reviewed to exclude studies that did not meet the selection criteria. In the end, a total of 14 studies were included, comprising 12 network meta-analyses (NMA) and 2 meta-analyses. All the efficacy results in the identities were extracted and summarized.

RESULTS: Compared to placebo in combination with docetaxel and androgen deprivation therapy (ADT), Darolutamide in combination with docetaxel and ADT further reduces the risk of death by 32%, and all relevant NMAs indicate that the Darolutamide regimen provides the greatest survival benefit. Compared to ARAT in combination with ADT, the Darolutamide regimen in combination with docetaxel and ADT also demonstrates the highest OS benefit. In high volume disease (HVD) populations, only the Darolutamide regimen shows significant benefit.

CONCLUSIONS: This study indicate that Darolutamide has significant therapeutic efficacy in the treatment of mHSPC. Compared to similar medications, Darolutamide improves patient prognosis in terms of prolonging overall survival, delaying progression to CRPC, thereby enhancing patients' quality of life.