Real-world comparison of androgen receptor pathway ınhibitors versus docetaxel as first-line treatment in metastatic hormone-sensitive prostate cancer.

BACKGROUND

Androgen receptor pathway inhibitors (ARPIs) and docetaxel are established first-line treatment options for metastatic hormone-sensitive prostate cancer (mHSPC); however, no randomized head-to-head trials have directly compared these strategies. We aimed to evaluate the efficacy of ARPI versus docetaxel as first-line treatment in patients with mHSPC.

METHODS

We retrospectively analyzed 148 patients with mHSPC treated with either ARPI (abiraterone, enzalutamide, or apalutamide) plus androgen deprivation therapy (ADT) (n = 98) or docetaxel plus ADT (n = 50). The primary endpoints were radiological progression-free survival (rPFS) and overall survival (OS). Survival outcomes were estimated using the Kaplan-Meier method and compared by log-rank test. Prognostic factors were assessed using univariate and multivariate Cox regression analyses.

RESULTS

At a median follow-up of 56.2 months, ARPI-based therapy was associated with significantly longer rPFS compared with docetaxel (median 68.6 vs. 18.9 months, p < 0.001). This rPFS benefit was consistent across subgroups defined by age, disease risk, disease volume, and visceral metastasis status. In multivariate analysis, ARPI treatment remained an independent predictor of prolonged rPFS (HR = 0.36, 95% CI = 0.23-0.58, p < 0.001). In contrast, OS did not differ significantly between the two treatment groups (median 79.8 vs. 62.2 months, p = 0.392), with no significant subgroup differences observed.

CONCLUSION

In this real-world cohort, ARPI-based therapy was associated with an improvement in rPFS compared with docetaxel, while OS outcomes remained comparable. In the absence of direct randomized comparisons, these findings may provide supportive real-world evidence for the clinical relevance of ARPI-based therapy as a first-line treatment option for patients with mHSPC.