Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Ketaconazole (Drug); Hydrocortisone (Drug); Dutasteride (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Beth Israel Deaconess Medical Center
Official(s) and/or principal investigator(s):
Steven Balk, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center
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
Official title: A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: To evaluate the efficacy of high dose ketoconazole and hydrocortisone in combination with dutasteride (KHAD) in the treatment of hormone refractory prostate cancer.
To evaluate the toxicity of the combination in hormone refractory prostate cancer.
To evaluate the time to progression on KHAD.
Correlate levels of androgens and metabolites with response.
- 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
- Participants may remain on study drug until there is evidence of disease progression.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
- PSA of greater than or equal to 2ng/ml and serum total testosterone less than or equal
- 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
- ECG showing a normal QT interval
- 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
Locations and Contacts
Sunnybrook and Women's College Health Sciences Center, Toronto, Canada
Sidney 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
Starting date: February 2005
Last updated: May 5, 2008