Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

NCT ID: NCT00673127

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2012-12-31

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 approved combination will make the combination more effective in treating prostate cancer.

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 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KHAD

Ketoconazole, Hydrocortisone and Dutasteride Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Dutasteride: 0.5 mg once a day

Group Type: EXPERIMENTAL

Ketoconazole, Hydrocortisone and Dutasteride

Intervention Type: DRUG

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

Interventions

Ketoconazole, Hydrocortisone and Dutasteride

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

Intervention Type: DRUG

Other Intervention Names

Dutasteride=Avodart

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Steven Balk, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Balk, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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

Countries

United States; Canada

Other Identifiers

04-414

Identifier Type: -

Identifier Source: org_study_id