At a glance
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Assessing PSA Response in Low Dose Ketoconazole in Hormone Refractory Prostate Cancer Patients Who Have Failed at Least One Prior Systemic Chemotherapy Regimen
In Brief
A Phase 2 clinical trial evaluating Ketoconazole and Hydrocortisone for Prostate Cancer. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The purpose of this study is to test the safety of ketoconazole and how well it works after chemotherapy has been used. Ketoconazole at lower doses has been used for fungal infections however has not yet been approved by the Food and Drug Administration for use in prostate cancer. Ketoconazole has been used for many years at high doses for prostate cancer, and this study will be to look at use of lower dose ketoconazole after someone has received chemotherapy. Ketoconazole works by halting the production of steroids in your body, including testosterone, and is thought to work directly on prostate cancer cells in published lab studies.
Study Details
Timeline
Interventions
Ketoconazole is taken three times a day by mouth.
Hydrocortisone is taken by mouth 20 mg every morning and 10 mg every evening.