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Keto/Dex in Castration Resistant Prostate Cancer
NCT01036594Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2009
- Primary completion
- Dec 2012
- Countries
- 1
- Sponsor
- University of California, San Francisco
- Modality
- Orthosteric Ligands
- Drugs
- dexamethasone
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label trial of dexamethasone in prostate cancer (PCa) (2 arms), sponsored by University of California, San Francisco. Primary endpoint: Number of Participants Who Achieved a Second Decline in Prostate Specific Antigen (PSA) Following Progression on First Regimen up to 5 years. Started Dec 2009; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Ketoconazole + Hydrocortisone
Initial treatment regimen
Ketoconazole + Dexamethasone
Second-line regimen upon progression
03
Endpoints
Primary
Number of Participants Who Achieved a Second Decline in Prostate Specific Antigen (PSA) Following Progression on First Regimen
Secondary
Median Change Over Time in Adrenocorticotrophic Hormone (ACTH) Levels
Change in Testosterone Levels Over Time for Participants on Dexamethasone
Change in Estrodiol Levels Over Time for Participants on Dexamethasone
Change in Serum Adrenal Androgen (AA) Levels Over Time for Participants on Dexamethasone
Change in Cortisol Levels Over Time for Participants on Dexamethasone
Change in Dehydroepiandrosterone (DHEA) Levels Over Time for Participants on Dexamethasone
Change in Dehydroepiandrosterone Sulfate (DHEA-S) Levels Over Time for Participants on Dexamethasone
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