drugset / Trial / NCT02961257
Trial Evaluating the Safety of 2 Schedules of Cabazitaxel in Elderly Men With mCRPC Previously Treated With a Docetaxel
Phase 3
Completed
196 enrolled
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.
Timeline
- Start
- 2017-05-05
- Primary completion
- 2021-12-02
- Completion
- 2021-12-02
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.
- Oudard S, Ratta R, Voog E, Barthelemy P, Thiery-Vuillemin A, Bennamoun M, Hasbini A, Aldabbagh K, Saldana C, Sevin E, Amela E, Von Amsberg G, Houede N, Besson D, Feyerabend S, Boegemann M, Pfister D, Schostak M, Huillard O, Di Fiore F, Quivy A, Lange C, Phan L, Belhouari H, Tran Y, Kotti S, Helissey C. Biweekly vs Triweekly Cabazitaxel in Older Patients With Metastatic Castration-Resistant Prostate Cancer: The CABASTY Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Dec 1;9(12):1629-1638. doi: 10.1001/jamaoncol.2023.4255.
- Pobel C, Auclin E, Procureur A, Clement-Zhao A, Simonaggio A, Delanoy N, Vano YA, Thibault C, Oudard S. Cabazitaxel schedules in metastatic castration-resistant prostate cancer: a review. Future Oncol. 2021 Jan;17(1):91-102. doi: 10.2217/fon-2020-0672. Epub 2020 Dec 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 16 mg/m2 | Intravenous |
| Subject | Cabazitaxel | Other / unclassified | 25 mg/m2 | Intravenous |
| Background | Lenograstim | Protein / enzyme biologic | — | Other |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |