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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer, Adenocarcinoma of Prostate

Thank you

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