Conditions: Prostate Cancer
Keywords: PSA Ketoconazole Prostate Cancer Hormone Refractory Chemotherapy Regimen
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief 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.

Detailed description:
The aim of the study is to research the response of low dose ketoconazole in hormone refractory prostate cancer (HRPC) patients who have already undergone chemotherapy as part of their prostate cancer treatment. The hypothesis of the study is that HRPC patients who have been previously treated with chemotherapy will demonstrate objective PSA response rates to low dose ketoconazole, comparable to historical response rates reported in chemotherapy-naïve patients. This is a single arm trial, with all participants given ketoconazole 200mg TID, along with hydrocortisone given at 20mg in the morning, 10mg at night daily. Each cycle will consist of 28 days. The subject's study participation will continue until subject experiences disease progression, unacceptable toxicities, withdraws consent from the study or dies.

Arms:
arm 1: Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm

Interventions: intervention 1: Ketoconazole intervention 2: Hydrocortisone
Intervention descriptions: intervention 1: Ketoconazole is taken three times a day by mouth. intervention 2: Hydrocortisone is taken by mouth 20 mg every morning and 10 mg every evening.

Protocol document: