Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Abiraterone Acetate (II) vs Original Abiraterone in mCRPC
NCT06768255Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Jan 2025
- Primary completion
- Dec 2028
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- abiraterone
- Conditions
- metastatic castration-resistant prostate cancer (mCRPC)
01
Overview
Phase 3, randomised, open-label trial of abiraterone in metastatic castration-resistant prostate cancer (mCRPC) (2 arms). Primary endpoint: Prostate-Specific Antigen 50 Response Rate at 24 months. Planned start Jan 2025; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Abiraterone Acetate (II)
Abiraterone Acetate (II) 300 mg qd + Prednisone 5 mg bid + ADT
Abiraterone Acetate (Zeke)
Abiraterone Acetate 1000 mg qd + Prednisone 5 mg bid + ADT
03
Who it enrols
Adult males with mCRPC, ECOG 0-1, and adequate organ function who have not received prior abiraterone or other novel AR antagonists in the mCRPC setting.
04
Endpoints
Primary
Prostate-Specific Antigen 50 Response Rate
Secondary
Objective Response Rate
Prostate-Specific Antigen Response Rate
Incidence of Adverse Events
Radiographic Progression-Free Survival
Overall Survival
Time to Prostate-Specific Antigen Progression
Time to Pain Progression
Beyond the preview
Go deeper on NCT06768255.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT06768255.