Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer

Summary

Primary Objective: \- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen. Secondary Objectives: * To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m². * To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for: * Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause; * PSA Progression; * Pain progression; * Tumor response in participants with measurable disease (RECIST 1.1); * PSA response; * Pain response in participants with stable pain at baseline. * To compare Health-related Quality of Life (HRQoL). * To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.

Timeline

Start

2011-04

Primary completion

2015-08

Completion

2015-08

Publications

• Vauchier C, Thibault C, Velev M, Becker O, Guillaume Z, Ashton E, Zaibet S, Berthou H, Courtinat F, Gervais C, Rochand A, Robbrecht D, Oudard S, Auclin E. Integrated Prognostic Score in Metastatic Castration-resistant Prostate Cancer Treated with Cabazitaxel - A CABASTY Post Hoc Analysis Validated by Two International Prospective Phase 3 Trials. Eur Urol Oncol. 2026 Apr 21:S2588-9311(26)00081-7. doi: 10.1016/j.euo.2026.03.022. Online ahead of print.
• Meisel A, de Wit R, Oudard S, Sartor O, Stenner-Liewen F, Shun Z, Foster M, Ozatilgan A, Eisenberger M, de Bono JS. Neutropenia, neutrophilia, and neutrophil-lymphocyte ratio as prognostic markers in patients with metastatic castration-resistant prostate cancer. Ther Adv Med Oncol. 2022 Jun 1;14:17588359221100022. doi: 10.1177/17588359221100022. eCollection 2022.
• Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.
• Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Mace S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.
• Eisenberger M, Hardy-Bessard AC, Kim CS, Geczi L, Ford D, Mourey L, Carles J, Parente P, Font A, Kacso G, Chadjaa M, Zhang W, Bernard J, de Bono J. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017 Oct 1;35(28):3198-3206. doi: 10.1200/JCO.2016.72.1076. Epub 2017 Aug 15.
• Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.

Drugs

Indications