Mifepristone (RU-486) in Androgen Independent Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer, Adenocarcinoma of Prostate

In brief

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

Key facts

Study ID: NCT00140478
Run by: Dana-Farber Cancer Institute
People needed: 48
Starts: 2005-02-01
Expected to finish: 2008-01-01
Last updated by the study team: 2009-12-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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