drugset / Trial / NCT02543255
Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial)
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in patients with high-risk prostate carcinoma. Half of the participants will receive treatment with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will receive only abiraterone acetate, prednisone, and leuprolide.
Timeline
- Start
- 2016-09
- Primary completion
- 2021-05-27
- Completion
- 2021-07-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 20 mg/m2 | — |
| Background | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Background | Leuprolide | Other / unclassified | 22.5 mg | Subcutaneous |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | — |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |