Docetaxel represent the standard of care in patients with metastatic hormone sensitive prostate cancer (mHSPC). However, androgen receptor axis targeted (ARAT) therapies, also have shown to be effective. We aimed to analyze findings from RCTs investigating first-line treatment for mHSPC.

A systematic literature review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and the Population, Intervention, Comparator, Outcomes (PICO) methodology. Outcome of interest were: overall survival (OS), progression-free survival (PFS) and high grade adverse events rates.

Compared to docetaxel, none of the other treatments was superior in terms of OS. However, abiraterone (HR: 0.89, 95% CI: 0.76-1.05), enzalutamide (HR: 0.90, 95% CI: 0.69-1.19) and apalutamide (HR: 0.90, 95% CI: 0.67-1.22) showed non-statistically significant lower overall mortality rates compared to docetaxel. Moreover, abiraterone (HR: 0.71, 95% CI: 0.59-0.86), enzalutamide (HR: 0.61, 95% CI: 0.49-0.75) and apalutamide (HR: 0.74, 95% CI: 0.57-0.95) showed statistically significant lower disease progression rates compared to docetaxel. Furthermore, abiraterone (OR: 0.83, 95% CI: 0.56-1.21) showed not statistically significant lower high grade adverse events rates compared to docetaxel. Finally, enzalutamide (OR: 0.56, 95% CI: 0.35-0.92) and apalutamide (OR: 0.44, 95% CI: 0.24-0.79) showed statistically significant lower high grade adverse events rates compared to docetaxel.

Treatment with ARATs in combination with ADT in patients with mHSPC does not offer statistically significant advantage in terms of OS compared to the standard docetaxel, but it is associated with lower disease progression rates. Moreover, apalutamide and enzalutamide offer a better safety profile.