At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed prostate cancer with progressive disease (2+ new bone lesions, progressive CT/MRI per RECIST 1.1, or rising PSA with minimum 2 ng/ml baseline and ≥2 successive rises ≥2 weeks apart)
- ✓Evidence of castration resistance: disease progression despite testosterone <50 ng/dL or surgical castration
- ✓ECOG performance status 0 or 1
- ✓Total bilirubin ≤1.5 × upper limit of normal
- ✕Prior abiraterone therapy
- ✕Hormonal therapies including megestrol acetate, finasteride, dutasteride, herbal PSA-lowering products, or systemic corticosteroids (except prednisone ≤10 mg/day) within 4 weeks prior to first dose
- ✕Supplements or complementary medicines/botanicals within 4 weeks (exceptions: conventional multivitamin, selenium, lycopene, soy supplements)
- ✕Inability to swallow capsules or known gastrointestinal malabsorption
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomized Pilot Study Evaluating the Food Effect on the Pharmacokinetics and Pharmacodynamics of Abiraterone Acetate in Men With Castrate Resistant Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating abiraterone acetate for Castration-resistant Prostate Cancer and Stage IV Prostate Cancer. Completed, enrolled 72 participants across 6 sites in 2 countries.
Detailed Summary
This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.
Study Details
Timeline
Interventions
Given PO