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Mifepristone (RU-486) in Androgen Independent Prostate Cancer

Primary Purpose

Prostate Cancer, Adenocarcinoma of Prostate

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mifepristone
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Androgen Independent Prostate Cancer, Prostate Cancer, Mifepristone, RU-486

Eligibility Criteria

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

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

Sites / Locations

  • Georgetown University
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2005
Last Updated
December 7, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women's Hospital, Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT00140478
Brief Title
Mifepristone (RU-486) in Androgen Independent Prostate Cancer
Official Title
A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women's Hospital, Georgetown University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Adenocarcinoma of Prostate
Keywords
Androgen Independent Prostate Cancer, Prostate Cancer, Mifepristone, RU-486

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
RU-486
Intervention Description
200mg orally once daily
Primary Outcome Measure Information:
Title
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary-Ellen Taplin, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
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
02115
Country
United States

12. IPD Sharing Statement

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Mifepristone (RU-486) in Androgen Independent Prostate Cancer

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