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VA-BAT in mCRPC with ATM, CDK12 or CHEK2 Deficiency
NCT05011383Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2021
- Primary completion
- Aug 2027
- Countries
- 1
- Sponsor
- VA Office of Research & Development
- Modality
- Small Molecules
- Drugs
- testosterone
- Conditions
- metastatic castration-resistant prostate cancer (mCRPC)
01
Overview
Phase 2, open-label trial of testosterone in metastatic castration-resistant prostate cancer (mCRPC) (3 arms), sponsored by VA Office of Research & Development. Primary endpoint: Prostate-Specific Antigen response at 12 weeks. Started Aug 2021; status: recruiting.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
ATM
Patients with mCRPC containing ATM alterations treated with high dose testosterone
CDK12
Patients with mCRPC containing CDK12 alterations treated with high dose testosterone
CHEK2
Patients with mCRPC containing CHEK2 alterations treated with high dose testosterone
03
Who it enrols
Men with metastatic castration-resistant prostate cancer (adenocarcinoma) who have progressed on at least one next-generation AR-signaling inhibitor, are maintained on androgen deprivation therapy, and have inactivating mutations in ATM, CDK12, or CHEK2.
04
Endpoints
Primary
Prostate-Specific Antigen response
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