KHAD
A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Sponsor study identifier
interventional
57
2 countries
7
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2012
Actual (reported)Study Completion
December 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
May 5, 2008
Actual (reported)May 7, 2008
Actual (reported)February 2012
Actual (reported)December 2012
Actual (reported)April 22, 2015
Actual (reported)PSA Response
PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
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. Maximum 32 months
Ketoconazole, Hydrocortisone and Dutasteride Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Dutasteride: 0.5 mg once a day
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Ketoconazole, Hydrocortisone and Dutasteride
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordSidney Kimmel Comprehensive Cancer Center at John Hopkins University
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02214, United States
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
Steven Balk, MD
Beth Israel Deaconess Medical Center
57 participants (actual enrollment reported by the registry).
First Submitted
May 5, 2008
First Posted
May 7, 2008
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Toronto, Canada
Primary Completion
February 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
April 22, 2015
Results First Posted
April 22, 2015
Record last verified: 2015-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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