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Low-dose abiraterone acetate (AA) with food showed similar efficacy and safety to standard dosing in metastatic castration-resistant prostate cancer (mCRPC). This cost-effective approach may be a viable alternative for patients with mCRPC.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Abiraterone acetate (AA) is a standard treatment for metastatic castration-resistant prostate cancer (mCRPC).
  • Standard AA dosing (1000 mg fasting) presents challenges in resource-limited settings due to fasting requirements and cost.
  • Pharmacokinetic data suggest low-dose AA (250 mg with food) may offer comparable drug exposure.

Purpose of the Study:

  • To compare the clinical efficacy and safety of low-dose AA (250 mg with food) versus standard-dose AA (1000 mg fasting) in patients with mCRPC.
  • To evaluate secondary endpoints including PSA responses, progression-free survival, overall survival, quality of life, and pharmacokinetics.

Main Methods:

  • A multicenter, open-label, phase III noninferiority trial randomized 164 patients with mCRPC 1:1 to low-dose or standard-dose AA.
  • The primary endpoint was prostate-specific antigen progression-free survival (PSA-PFS).
  • The trial was underpowered due to slow accrual, preventing noninferiority testing.

Main Results:

  • PSA30 and PSA50 response rates were similar between low-dose (50.0%, 38.5%) and standard-dose (55.4%, 45.9%) AA.
  • Median PSA-PFS (5.7 vs. 3.8 months), overall PFS, and overall survival (18.1 vs. 15.8 months) were comparable.
  • Grade ≥3 toxicities were similar (38.3% vs. 30.0%), and quality of life scores were comparable between groups.

Conclusions:

  • Despite being underpowered, the trial suggests low-dose AA with food yields broadly similar outcomes to standard dosing in mCRPC.
  • The low-dose regimen demonstrated maintained safety and quality of life.
  • This cost-conscious approach may represent a feasible alternative, warranting further investigation.