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. 2024 Mar;12(1):46-51.
doi: 10.1016/j.prnil.2023.12.002. Epub 2023 Dec 19.

Real-world effects of novel androgen receptor axis-targeted agents on oncological outcomes in non-metastatic castration-resistant prostate cancer: A multi-institutional retrospective study

Naoki Fujita  1 , Shingo Hatakeyama  2 , Ryuji Tabata  3 , Kazutaka Okita  1 , Koichi Kido  1 , Itsuto Hamano  1 , Toshikazu Tanaka  1 , Daisuke Noro  1 , Noriko Tokui  1 , Yuichiro Suzuki  1 , Takahiro Yoneyama  4 , Yasuhiro Hashimoto  1 , Satoshi Sato  5 , Chikara Ohyama  1   4
Affiliations

Real-world effects of novel androgen receptor axis-targeted agents on oncological outcomes in non-metastatic castration-resistant prostate cancer: A multi-institutional retrospective study

Naoki Fujita et al. Prostate Int. 2024 Mar.

Abstract

Background: The benefits of novel androgen receptor axis-targeted agents (ARATs) on oncological outcomes in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in real-world settings are unclear.

Methods: This multi-institutional retrospective study included 178 patients with nmCRPC treated between September 2003 and August 2022. Patients were divided into two groups: those who were treated with any novel ARATs, including apalutamide, enzalutamide, darolutamide, and abiraterone acetate, during any line of nmCRPC treatment (novel ARATs group) and those who were not (control group). Multivariable Cox proportional hazards regression analyses were performed to evaluate the effects of novel ARATs on metastasis-free survival (MFS) and overall survival (OS).

Results: The median age and follow-up period after nmCRPC diagnosis were 76 years and 37 months, respectively. Of the 178 patients, 122 (69%) were treated with novel ARATs after nmCRPC diagnosis. The MFS and OS in the novel ARATs group were significantly longer than those in the control group (P < 0.001 and P = 0.020, respectively). In multivariable analyses, a prostate-specific antigen doubling time (PSADT) of <3 months and novel ARATs were independently and significantly associated with MFS and OS. The effects of novel ARATs on MFS were consistently observed across subgroups stratified by age (<75 years or ≥75 years), history of radical treatment (no or yes), biopsy Gleason score (<9 or ≥9), clinical stage (≤cT3 and cN0, or cT4 or cN1), and PSADT (≥3 months or <3 months).

Conclusion: Novel ARATs were significantly associated with improved oncological outcomes in patients with nmCRPC in a real-world setting, regardless of tumor aggressiveness.

Keywords: Novel ARATs; Oncological outcomes; PSA doubling time; Real-world; nmCRPC.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Patient selection. Numbers of patients included and excluded. CRPC, castration-resistant prostate cancer; nmCRPC, non-metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; nmCSPC, non-metastatic castration-sensitive prostate cancer; mCRPC, metastatic castration-resistant prostate cancer; ARATs, androgen receptor axis-targeted agents.
Fig. 2
Fig. 2
Prostate-specific antigen doubling time (PSADT) distribution and correlation between metastasis-free survival (MFS) and overall survival (OS). The PSADT distribution in all patients (A). The correlation between MFS and OS was analyzed using Spearman's rank correlation coefficient (B).
Fig. 3
Fig. 3
Metastasis-free survival and overall survival. Metastasis-free survival (A) and overall survival (B) after non-metastatic castration-resistant prostate cancer (nmCRPC) diagnosis were evaluated using the Kaplan–Meier method and compared using the log-rank test. ARATs, androgen receptor axis-targeted agents.
Fig. 4
Fig. 4
Metastasis-free survival (MFS) in subgroup analyses. Subgroup analyses on MFS using Cox-proportional hazards regression analyses were performed. ARATs, androgen receptor axis-targeted agents; PSADT, prostate-specific antigen doubling time; NR, not reached.
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