Status:
COMPLETED
Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Massachusetts General Hospital
Dana-Farber Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
* 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 the...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00673127
Start Date
February 1 2005
End Date
December 1 2012
Last Update
April 22 2015
Active Locations (7)
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1
Sidney Kimmel Comprehensive Cancer Center at John Hopkins University
Baltimore, Maryland, United States
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214