CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
Ketoconazole, Hydrocortisone and Dutasteridedrug
Likely dose
Ketoconazole, Hydrocortisone and Dutasteride 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00673127
NCT00673127Phase 2Completed
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A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

Beth Israel Deaconess Medical Center·interventional·Posted May 7, 2008·Updated Apr 22, 2015

In Brief

A Phase 2 clinical trial evaluating Ketoconazole, Hydrocortisone and Dutasteride for Prostate Cancer. Completed, enrolled 57 participants across 7 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, United States
CollaboratorsMassachusetts General Hospital, Dana-Farber Cancer Institute, Sunnybrook Health Sciences Centre, Oregon Health and Science University, M.D. Anderson Cancer Center, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2008
Enrollment StartFeb 1, 2005
Primary CompletionFeb 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 18.2 years ago

Interventions

Ketoconazole, Hydrocortisone and Dutasteridedrug

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