Back to results

Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer (KHAD)

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ketoconazole, Hydrocortisone and Dutasteride

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring hormone refractory, KHAD, ketoconazole, dutasteride, hydrocortisone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at John Hopkins University
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Massachusetts General Hospital
Oregon Health and Science University
MD Anderson Cancer Center
Sunnybrook and Women's College Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KHAD

Arm Description

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

Outcomes

Primary Outcome Measures

PSA Response

PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.

Secondary Outcome Measures

Time to Progression

Duration of time from treatment initiation until documented progression (PSA or Disease progression)

Full Information

NCT ID

NCT00673127

First Posted

May 5, 2008

Last Updated

April 20, 2015

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Massachusetts General Hospital, Dana-Farber Cancer Institute, Sunnybrook Health Sciences Centre, Oregon Health and Science University, M.D. Anderson Cancer Center, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1. Study Identification

Unique Protocol Identification Number

NCT00673127

Brief Title

Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

Acronym

KHAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

hormone refractory, KHAD, ketoconazole, dutasteride, hydrocortisone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KHAD

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ketoconazole, Hydrocortisone and Dutasteride

Other Intervention Name(s)

Dutasteride=Avodart

Intervention Description

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

Primary Outcome Measure Information:

Title

PSA Response

Description

PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.

Time Frame

From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.

Secondary Outcome Measure Information:

Title

Time to Progression

Description

Duration of time from treatment initiation until documented progression (PSA or Disease progression)

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Balk, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at John Hopkins University

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02214

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

Country

United States

Facility Name

Sunnybrook and Women's College Health Sciences Center

City

Toronto

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

We'll reach out to this number within 24 hrs