Mifepristone (RU-486) in Androgen Independent Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140478
• Other study ID #: 04-249
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2005
• Last updated: December 7, 2009
• Start date: February 2005
• Est. completion date: January 2008

Study information

• Verified date: December 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Prostate
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Mifepristone
200mg orally once daily

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Georgetown University	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Georgetown University, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer		2 years	No
Secondary	To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer		TBD	Yes