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.
* Participants will be seen by the study physician every four weeks and have a short physical examination, blood tests and be asked to provide information about their condition. Every three months they will undergo a bone scan. If the CT scan that was obtained before the participant started the study shows evidence of cancer, they will be asked to repeat this test every three months. * Ketaconazole will be taken orally three times a day on an empty stomach. Hydrocortisone will be taken orally in the morning and at night. Dutasteride will be taken orally once a day. * Participants may remain on study drug until there is evidence of disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Pills should be taken with food or milk. Dutasteride: 0.5mg orally once a day on an empty stomach or after eating a meal
Sidney Kimmel Comprehensive Cancer Center at John Hopkins University
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
PSA Response
PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
Time frame: From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.
Time to Progression
Duration of time from treatment initiation until documented progression (PSA or Disease progression)
Time frame: Duration of time from treatment initiation until documented progression. Maximum 32 months
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Oregon Health and Science University
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
Sunnybrook and Women's College Health Sciences Center
Toronto, Canada