Study of Dose Escalation of Abiraterone Actetate in Prostate Cancer

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

Timeline

Start

2018-06-22

Primary completion

2021-04-29

Completion

2021-12-27

Publications

• Background Carton E, Noe G, Huillard O, Golmard L, Giroux J, Cessot A, Saidu NE, Peyromaure M, Zerbib M, Narjoz C, Guibourdenche J, Thomas A, Vidal M, Goldwasser F, Blanchet B, Alexandre J. Relation between plasma trough concentration of abiraterone and prostate-specific antigen response in metastatic castration-resistant prostate cancer patients. Eur J Cancer. 2017 Feb;72:54-61. doi: 10.1016/j.ejca.2016.11.027. Epub 2016 Dec 24.
• Results Alexandre J, Oudard S, Golmard L, Campedel L, Mseddi M, Ladoire S, Khalil A, Maillet D, Tournigand C, Pasquiers B, Goirand F, Berthier J, Guitton J, Dariane C, Joly F, Xylinas E, Golmard JL, Abdoul H, Puszkiel A, Decleves X, Carton E, Thomas A, Vidal M, Huillard O, Blanchet B. Intra-individual Dose Escalation of Abiraterone According to Its Plasma Exposure in Patients with Progressive Metastatic Castration-Resistant Prostate Cancer: Results of the OPTIMABI Trial. Clin Pharmacokinet. 2024 Jul;63(7):1025-1036. doi: 10.1007/s40262-024-01396-x. Epub 2024 Jul 4.

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