drugset / Trial / NCT04139772
Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized phase 3 trial aiming to compare the efficacy of docetaxel and hormone therapy as second line treatment in patients with mCRPC progressing after therapy with abiraterone or enzalutamide.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2023-12-01
- Completion
- 2024-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 5 mg | Oral |