Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer
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.
Timeline
- Start
- 2012-01
- Primary completion
- 2017-09
- Completion
- 2017-12
Outcome
Met primary endpoint
paper noninferiority of LOW was established according to predefined criteria. PMID 29590007 ↗
paper At 12 weeks, there was a greater effect on PSA in the LOW arm (mean log change, -1.59) compared with STD (-1.19) PMID 29590007 ↗
registry analysis (non-inferiority test); Arm I (Fasting) vs Arm II (Fed); p <0.10 NCT01543776 ↗
Publications
- Heiss BL, Geynisman DM, Martinez E, Wong ASC, Yong WP, Szmulewitz RZ, Stadler WM. Comparison of out-of-pocket costs and adherence between the two arms of the prospective, randomized abiraterone food effect trial. Support Care Cancer. 2022 Mar;30(3):2803-2810. doi: 10.1007/s00520-021-06670-3. Epub 2021 Nov 29.
- Szmulewitz RZ, Peer CJ, Ibraheem A, Martinez E, Kozloff MF, Carthon B, Harvey RD, Fishkin P, Yong WP, Chiong E, Nabhan C, Karrison T, Figg WD, Stadler WM, Ratain MJ. Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer. J Clin Oncol. 2018 May 10;36(14):1389-1395. doi: 10.1200/JCO.2017.76.4381. Epub 2018 Mar 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 250 mg | Oral |
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |