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A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
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
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
Start Date
February 1, 2005
Primary Completion Date
February 1, 2012
Completion Date
December 1, 2012
Last Updated
April 22, 2015
57
ACTUAL participants
Ketoconazole, Hydrocortisone and Dutasteride
DRUG
Lead Sponsor
Beth Israel Deaconess Medical Center
Collaborators
NCT05691465
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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