Mifepristone (RU-486) in Androgen Independent Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer; Adenocarcinoma of Prostate

• Registration Number: NCT00140478
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Primary Completion: 2006-06
• Study Completion: 2008-01
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-07
• Last Update Posted: 2009-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States