A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
18 Years
N/A
Male
Prostate Cancer, Adenocarcinoma of Prostate
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Mary-Ellen Taplin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
04-249
NCT ID:
NCT00140478
Start Date:
February 2005
Completion Date:
January 2008
Related Keywords:
- Prostate Cancer
- Adenocarcinoma of Prostate
- Androgen Independent Prostate Cancer
- Prostate Cancer
- Mifepristone
- RU-486
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
Name | Location |
|---|---|
| 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 |
