Effect of Low-dose 500 mg Abiraterone Acetate in Treatment of Metastatic Prostate Cancer Patients
Status:
Active, not recruiting
Trial end date:
2026-09-01
Target enrollment:
Participant gender:
Summary
This will be an open label, Phase I study to assess the efficacy of a reduced 500 mg dose of
abiraterone acetate in patients with metastatic prostate cancer. Eligible metastatic
hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer
(mCRPC) patients newly initiated on abiraterone acetate treatment will be recruited to
receive a reduced 500 mg dose of abiraterone acetate plus prednisolone. The study treatment
duration will span 12 weeks, after which patients being administered the reduced dose will be
reverted to the standard 1000 mg dosing. Follow-up for mCRPC and mHSPC patients will last for
18 and 36 months respectively. The main question the study aims to answer is whether dose
reduction of abiraterone acetate to 500 mg would achieve antitumor activity in mCRPC and
mHPSC patients comparable to standard of care.