Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

Prostate Cancer Clinical Trial

— KHAD  

Official title:

A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673127
• Other study ID #: 04-414
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2008
• Last updated: April 20, 2015
• Start date: February 2005
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Sunnybrook and Women's College Health Sciences Center	Toronto
United States	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	MD Anderson Cancer Center	Houston	Texas
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (7)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Dana-Farber Cancer Institute, M.D. Anderson Cancer Center, Massachusetts General Hospital, Oregon Health and Science University, Sidney Kimmel Comprehensive Cancer Center, Sunnybrook Health Sciences Centre

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA Response	PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.	From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.	No
Secondary	Time to Progression	Duration of time from treatment initiation until documented progression (PSA or Disease progression)	Duration of time from treatment initiation until documented progression. Maximum 32 months	No