Study of Dose Escalation of Abiraterone Actetate in Prostate Cancer
Status:
Active, not recruiting
Trial end date:
2022-06-22
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test whether a dose escalation up to 2000 mg per day of
abiraterone acetate is feasible and lead to disease stabilization in castration-resistant
metastatic prostate cancer patients who experience disease progression within the first 6
months of abiraterone actetate at standard dose (1000 mg/d) and have a plasma abiraterone
concentration below 8.5 ng/mL.
It is a non-comparative phase 2 study in which patients will be included in two successive
steps. Patients with mCRPC will be included in the first step and treated with standard dose
(1000 mg/day) of ABI + prednisone /prednisolone (10 mg/d) according to the summary of product
characteristics and monitored for trough ABI plasma level each month for 3 months.
In the second step intrapatient ABI dose escalation (2000 mg/day) + prednisone/prednisolone
(10 mg/d) will be realized for patients from the first step experiencing progressive disease
within 6 months of ABI standard dose and with mean ABI plasma level during the first three
months < 8.5 ng/mL