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A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer (KHAD)
The combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating prostate cancer.
Details
| Lead sponsor | Beth Israel Deaconess Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 57 |
| Start date | 2005-02 |
| Completion | 2012-12 |
Conditions
- Prostate Cancer
Interventions
- Ketoconazole, Hydrocortisone and Dutasteride
Primary outcomes
- PSA Response — From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.
PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
Countries
United States, Canada