CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone
Summary
This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progression-free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT.
Timeline
- Start
- 2019-10-10
- Primary completion
- 2023-06-19
- Completion
- 2025-04-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Cabazitaxel | Other / unclassified | 20 mg/m2 | — |
| Subject | Carboplatin | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |