This clinical trial tests the best dose of abiraterone acetate in treating patients with prostate cancer who are receiving abiraterone for the first time. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by blocking tissues from making androgens (male hormones), such as testosterone. This may help shrink or slow the growth of cancer cells that need androgens to grow.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05276492.
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of different dosing regimens of abiraterone 500 mg as assessed by reduction in serum dihydroepiadrosterone sulfate (DHEA-S) level.
SECONDARY OBJECTIVES:
I. To evaluate the effects of different dosing regimens of abiraterone 500 mg on serum prostate specific antigen (PSA) levels.
II. To evaluate the safety profile of different dosing regimens of abiraterone 500 mg.
EXPLORATORY OBJECTIVES:
I. To evaluate the pharmacokinetic effects (minimum concentration [Cmin]) of different dosing regimens of abiraterone 500 mg.
II. To evaluate the effects of different dosing regimens of abiraterone 500 mg on other androgen levels (testosterone, etc.).
OUTLINE: Patients are assigned to 1 of 4 cohorts.
COHORT I: Patients receive abiraterone acetate orally (PO) every other day with a low fat breakfast for 12 weeks in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients receive abiraterone acetate PO on days 1, 3, and 5 with a low fat breakfast. Cycles repeat every 7 days for 12 weeks in the absence of disease progression or unacceptable toxicity.
COHORT III: Patients receive abiraterone acetate PO on days 1 and 4 with a low fat breakfast. Cycles repeat every 7 days for 12 weeks in the absence of disease progression or unacceptable toxicity.
COHORT IV: Patients receive abiraterone acetate PO once weekly with a low fat breakfast for 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 30 days.
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorRussell Zelig Szmulewitz
