Mifepristone (RU-486) in Androgen Independent Prostate Cancer

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00140478

Collaborator

Beth Israel Deaconess Medical Center (Other), Massachusetts General Hospital (Other), Brigham and Women's Hospital (Other), Georgetown University (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Adenocarcinoma of Prostate	Drug: Mifepristone	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jan 1, 2008

Outcome Measures

Primary Outcome Measures

To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer [2 years]

Secondary Outcome Measures

To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown University	Washington	District of Columbia	United States	20057
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02115