Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00673127
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 57
- Starts
- 2005-02-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2015-04-22
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). In the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum PSA and metastatic lesions on bone scan.
- Progressive HRPC defined as a PSA increase over baseline of >25% or 5ng/ml or new lesions on bone/CT scan after conventional androgen deprivation and antiandrogen withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not required.
- PSA of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml
- Prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy
- Prior therapy with estrogens is permitted but must have been discontinued > 4 weeks prior to registration
- ECOG Performance Status 0-2
- Adequate renal function, hepatic function, and bone marrow function as outlined in protocol
- ECG showing a normal QT interval
You may not qualify if…
- Prior therapy with ketoconazole or corticosteroids for HRPC
- Major surgery or radiation therapy within 4 weeks
- Strontium-89 or samarium-153 therapy within 4 weeks
- Thromboembolism in past 6 months
- Patients who are taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes.
- Concomitant use of drugs known to be narrow therapeutic index CTP3A4
- Drugs that are sensitive CYP3A4 substrates
- Alcohol or drug dependence currently or in the last 6 months
Where it is running
- 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
Full record on ClinicalTrials.gov
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