Mifepristone (RU-486) in Androgen Independent Prostate Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140478

Enrollment

Registered

2005-09-01

Start date

2005-02-28

Completion date

2008-01-31

Last updated

2009-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of Prostate, Prostate Cancer

Keywords

Androgen Independent Prostate Cancer, Prostate Cancer, Mifepristone, RU-486

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.

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.

Interventions

DRUGMifepristone

200mg orally once daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer	2 years

Secondary

Measure	Time frame
To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026