Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer
NCT00031889 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2012-05-15
Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using exemestane plus bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if exemestane is more effective with or without bicalutamide in treating prostate cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of exemestane with or without bicalutamide in treating patients who have stage IV prostate cancer that has been previously treated with hormone therapy or surgery.
Conditions
Interventions
- DRUG
-
Exemestane
Exemestane
- DRUG
-
Exemestane+bicalutamide
Exemestane as in arm I and oral bicalutamide once daily
Sponsors & Collaborators
-
Swiss Cancer Institute
lead OTHER
Principal Investigators
-
Marco Bonomo, MD · Ospedale Beata Vergine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-08-31
- Primary Completion
- 2002-06-30
- Completion
- 2002-06-30
Countries
- Switzerland
Study Locations
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