Mifepristone (RU-486) in Androgen Independent Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer, Adenocarcinoma of Prostate

Intervention / Treatment
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* Drug: Mifepristone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mifepristone|200mg orally once daily|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgen Independent Prostate Cancer, Prostate Cancer, Mifepristone, RU-486