Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01543776|
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Castration-resistant Prostate Cancer Stage IV Prostate Cancer||Drug: abiraterone acetate||Phase 2|
I. To compare the pharmacodynamic effect of reduced dose (250mg daily) abiraterone acetate in the prandial state (250mg-Fed) to the full, standard 1000mg daily dose in the fasting state (1000mg-Fasting) as assessed by change in serum prostate-specific antigen (PSA).
I. To evaluate the effect of prandial states on plasma levels and the intra-patient pharmacokinetic variability of abiraterone acetate.
II. To evaluate the safety profile of reduced dose abiraterone acetate taken in the prandial state.
III. To evaluate the pharmacodynamic effect of reduced dose abiraterone acetate in the prandial state as assessed by reduction in the extra-gonadal androgen dihydroepiadrosterone sulfate (DHEA-S) and dihydroepiandrostenedione (DHEA).
IV. To evaluate the effect of prandial state on time to disease progression (Working group criteria).
OUTLINE: Patients are randomized to one of two treatment arms.
ARM I: Patients receive abiraterone acetate orally (PO) daily first thing in morning after an overnight fast of at least 8 hours.
ARM II: Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Both arms will also be treated with prednisone 5mg twice daily.
After completion of study treatment, patients are followed up within 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Pilot Study Evaluating the Food Effect on the Pharmacokinetics and Pharmacodynamics of Abiraterone Acetate in Men With Castrate Resistant Prostate Cancer|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||December 2017|
Active Comparator: Arm I (fasting)
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
Drug: abiraterone acetate
Experimental: Arm II (fed)
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
Drug: abiraterone acetate
- Change in PSA Level [ Time Frame: From baseline to 12 weeks ]Data were analyzed on a log scale: log(week 12) - log(baseline) = log ratio. Smaller (more negative) values indicate a better outcome.
- Progression-free Survival (PFS) [ Time Frame: Assessed up to 3 years ]Time to PSA progression (25% increase from baseline), radiographic progression, or death.
- Adrenal Androgen Production (DHEA-S) [ Time Frame: Cycle 4 (4 months) ]Extragonadal serum adrogen
- Number of Participants With Adverse Events (AEs) [ Time Frame: Assessed up to 1 year ]Patients with grade 3 or higher AE (CTCAE Version 4.03)
- Peak Plasma Concentration of Abiraterone [ Time Frame: Up to 4 months ]Analyzed on a log scale due to skewness of distribution
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543776
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637-1470|
|North Shore University Health System|
|Evanston, Illinois, United States, 60201|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60430|
|Illinois Cancer Care|
|Peoria, Illinois, United States, 61615|
|National University Hospital|
|Principal Investigator:||Russell Szmulewitz||University of Chicago|