Mifepristone (RU-486) in Androgen Independent Prostate Cancer

December 7, 2009 updated by: Dana-Farber Cancer Institute

A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins

The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Mifepristone

Detailed Description

Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.

At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.

After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- District of Columbia
  - Washington, District of Columbia, United States, 20057
    - Georgetown University
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02115
    - Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Histologic documentation of adenocarcinoma of the prostate
Bone metastasis(es) by bone scan or cat scan
Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
One prior chemotherapy treatment is allowed.
> 3 weeks since major surgery
> 4 weeks since radiotherapy
> 8 weeks since prior strontium-89 or samarium 153
ECOG performance status 0 or 1
Absolute neutrophil count (ANC) > 1,500/ul
Platelets > 100,000/ul
Bilirubin < 1.5 x upper limit of normal (ULN)
AST or ALT < 3 x ULN
Creatinine < 1.5 x ULN
Electrolytes within 10% of normal range
Serum testosterone < 50ng/dL
Prostate-specific antigen (PSA) > 5.0ng/ml

Exclusion Criteria:

Concomitant therapy with corticosteroids
Chemotherapy within 28 days
Currently active second malignancy other than non-melanoma skin cancer
Baseline adrenal insufficiency requiring long-term steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome Measure
To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Georgetown University

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria