Mifepristone (RU-486) in Androgen Independent Prostate Cancer

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Georgetown University; Massachusetts General Hospital
• Treatments: Androgens; Mifepristone

Criteria

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