A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
Mary-Ellen Taplin, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Georgetown University||Washington, District of Columbia 20007-2197|