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ACTIVE NOT RECRUITING
NCT06193993
PHASE1

Effect of Low-dose 500 mg Abiraterone Acetate in Treatment of Metastatic Prostate Cancer Patients

Sponsor: National University Hospital, Singapore

View on ClinicalTrials.gov

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.

Official title: Low-dose 500 mg Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer (mCRPC) and Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Patients: a Phase I Proof-of-concept Clinical Study

Key Details

Gender

MALE

Age Range

21 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2021-11-30

Completion Date

2026-09

Last Updated

2024-01-08

Healthy Volunteers

No

Interventions

DRUG

Abiraterone Acetate

Upon successful registration, patients would be initiated on 500 mg once daily (two 250 mg tablets), plus prednisolone 5 mg twice daily orally for mCRPC and 5mg once daily orally for mHSPC.

Locations (1)

National University Hospital

Singapore, Singapore