Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

NCT00673127 | Completed Phase 2 Results DMC

• 1 other identifier: 04-414
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 7

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.

Conditions

Prostate Cancer

Keywords

hormone refractory; KHAD; ketoconazole; dutasteride; hydrocortisone

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Time to Progression

  Duration of time from treatment initiation until documented progression. Maximum 32 months

Study Arms (1)

KHAD

EXPERIMENTAL

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

Drug: Ketoconazole, Hydrocortisone and Dutasteride

Interventions

Ketoconazole, Hydrocortisone and Dutasteride 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

Also known as: Dutasteride=Avodart

KHAD

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Massachusetts General Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Oregon Health and Science University: collaborator
• M.D. Anderson Cancer Center: collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: collaborator

Study Sites (7)

Sidney Kimmel Comprehensive Cancer Center at John Hopkins University

Baltimore, Maryland, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

MD Anderson Cancer Center

Houston, Texas, United States

Location

Sunnybrook and Women's College Health Sciences Center

Toronto, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ketoconazole; Hydrocortisone; Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Azasteroids; Steroids, Heterocyclic

Results Point of Contact

• Title: Steven Balk
• Organization: Beth Israel Deaconess

sbalk@bidmc.harvard.edu

617-735-2065

Study Officials

• Steven Balk, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: February 1, 2005
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 22, 2015
• Results First Posted: April 22, 2015

Record last verified: 2015-04

Locations

CA (1); US (6)