Darolutamide-based triplet therapy versus androgen receptor pathway inhibitor-based doublet therapy for metastatic castration-sensitive prostate cancer: a real-world analysis using the TriNetX database.

Authors

Yoichiro Tohi, Yuri Kitadani, Takuma Kato, Shunsuke Nakamura, Naoya Kani, Iori Matsuda, Kana Kohashiguchi, Yohei Abe, Hirohito Naito, Homare Okazoe, Rikiya Taoka, Fumiaki Mikami, Mikio Sugimoto

Published in

Japanese journal of clinical oncology. Aug 28, 2026. Epub Aug 28, 2026.

Abstract

Currently, there are no large cohort studies comparing the clinical outcomes of triplet therapy with those of androgen receptor pathway inhibitor (ARPI)-based doublet therapy for patients with metastatic castration-sensitive prostate cancer (mCSPC) representing real-world practice. Therefore, the present study aimed to compare whether triplet or doublet therapy is more effective in patients with mCSPC.
This large-scale retrospective cohort study used TriNetX electronic medical record data from August 2018 to July 2026, enrolling patients with mCSPC categorized as receiving triplet [darolutamide + docetaxel + androgen deprivation therapy (ADT)] or doublet therapy (enzalutamide or apalutamide + ADT). The primary outcome was overall survival (OS), while the secondary outcome was the proportion of patients achieving a PSA level ≤ 0.2 ng/ml. Propensity score matching (PSM) (1:1) was conducted to adjust for confounding variables between groups.
Overall, 1841 patients met the eligibility criteria. Following PSM (n = 329), triplet therapy was associated with a statistically significant improvement in OS compared with doublet therapy (hazard ratio: 0.601; 95% confidence interval: 0.420-0.862; log-rank P = .005). The proportions of patients achieving PSA ≤0.2 ng/ml were 26.4% vs. 17.0% at 3 months (P = .003), 37.4% vs. 27.7% at 6 months (P = .008), 43.8% vs. 35.9% at 12 months (P = .038), and 50.5% vs. 40.1% at any time (P = .008) in the triplet and doublet groups, respectively.
In this real-world analysis using the TriNetX database, triplet therapy including darolutamide significantly improved OS and PSA decline compared with ARPI-based doublet therapy.

PMID:
42664274
Bibliographic data and abstract were imported from PubMed on 29 Aug 2026.

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