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Published on: March 6, 2018
Efficacy, Safety, and Cost-Effectiveness of Reduced versus Full Initial Doses of Androgen Receptor Signaling
Himawari Asanuma1, Naoki Fujita1, Shumon Kato2
1Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Background:
The introduction of novel androgen receptor signaling inhibitors (ARSIs) has substantially transformed the systemic treatment landscape for non-metastatic castration-resistant prostate cancer (nmCRPC). Unfortunately, ARSI therapy is associated with considerable adverse events (AEs) and high medical costs. Dose reduction has been proposed as a potential strategy to improve tolerability and reduce costs; however, the efficacy, safety, and cost-effectiveness of reduced-dose ARSIs in patients with nmCRPC remain unclear.
Methods:
This multicenter retrospective study included 251 patients with nmCRPC who underwent ARSI therapy. Patients were categorized into reduced-dose (n = 46) and full-dose (n = 205) groups according to the initial ARSI dose. The prostate-specific antigen progression-free survival (PSA-PFS), metastasis-free survival (MFS), and overall survival (OS) were compared between the groups. AEs and monthly medical costs for the first ARSI treatment were also evaluated.
Results:
No significant differences in PSA-PFS, MFS, or OS were observed between the two groups (p = 0.307, p = 0.199, and p = 0.287, respectively). Multivariable analysis showed that the initial ARSI dose was not significantly associated with MFS (p = 0.984). The incidence rates of any-grade and grade ≥ 3 AEs did not significantly differ between the two groups (p = 0.171 and P = 1.000, respectively). In contrast, the median monthly cost of the first ARSI treatment was significantly lower in the reduced-dose group than in the full-dose group ($998 vs. $1644, p < 0.001).
Conclusions:
Reduced-dose ARSI therapy was associated with comparable oncological outcomes to full-dose therapy in patients with nmCRPC, while suggesting potential cost savings. Dose reduction may be considered a treatment option in selected populations, such as elderly patients, who were predominant in our cohort.
Insights
Reduced-dose androgen receptor signaling inhibitors (ARSIs) offer comparable survival outcomes to full-dose ARSIs for non-metastatic castration-resistant prostate cancer (nmCRPC). This approach significantly lowers treatment costs, making it a viable option for select patients.
Area of Science:
- Oncology
- Pharmacology
- Health Economics
Background:
- Novel androgen receptor signaling inhibitors (ARSIs) have improved non-metastatic castration-resistant prostate cancer (nmCRPC) treatment.
- However, ARSI therapy presents challenges with adverse events and high costs.
- The efficacy, safety, and cost-effectiveness of reduced-dose ARSIs in nmCRPC are not well-established.
Purpose of the Study:
- To evaluate the oncological outcomes, safety, and cost-effectiveness of reduced-dose versus full-dose ARSI therapy in patients with nmCRPC.
- To determine if dose reduction impacts prostate-specific antigen progression-free survival (PSA-PFS), metastasis-free survival (MFS), and overall survival (OS).
Main Methods:
- A multicenter retrospective study analyzed 251 nmCRPC patients treated with ARSI.
- Patients were divided into reduced-dose (n=46) and full-dose (n=205) groups.
- Comparisons included PSA-PFS, MFS, OS, adverse events (AEs), and monthly medical costs.
Main Results:
- No significant differences were found in PSA-PFS, MFS, or OS between reduced-dose and full-dose groups.
- The incidence of any-grade and grade ≥3 AEs did not differ significantly between the groups.
- Median monthly ARSI treatment costs were substantially lower in the reduced-dose group ($998 vs. $1644).
Conclusions:
- Reduced-dose ARSI therapy demonstrates comparable oncological outcomes to full-dose therapy in nmCRPC patients.
- Dose reduction presents a potential strategy for significant cost savings.
- Consideration of reduced-dose ARSI therapy may be appropriate for selected nmCRPC populations, such as elderly patients.
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