Mifepristone (RU-486) in Androgen Independent Prostate Cancer
NCT ID: NCT00140478
Last Updated: 2009-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2005-02-28
2008-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Mifepristone
200mg orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Chemotherapy within 28 days
* Currently active second malignancy other than non-melanoma skin cancer
* Baseline adrenal insufficiency requiring long-term steroids
18 Years
MALE
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Massachusetts General Hospital
OTHER
Brigham and Women's Hospital
OTHER
Georgetown University
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Dana-Farber Cancer Institute
Principal Investigators
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Mary-Ellen Taplin, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Georgetown University
Washington D.C., District of Columbia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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04-249
Identifier Type: -
Identifier Source: org_study_id