MedTrace Logo

Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

NCT00673127 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2015-04-22

Study results available
· View outcomes & findings →

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

Interventions

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    collaborator OTHER

  • Beth Israel Deaconess Medical Center

    lead OTHER

Principal Investigators

  • Steven Balk, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2012-02-29
Completion
2012-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00673127 on ClinicalTrials.gov