Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study
- Patients will be randomly assigned to initial treatment with either rosiglitazone or
placebo orally twice daily, every day as long as there is no disease progression or
serious side effects. Patients will be asked to complete a drug log to keep track of
- Before treatment begins the following tests will be performed: physical exam; bone
scan; blood work (including PSA level test) and a urine sample.
- While on this study the following tests and procedures will be done once a month:
review of side effects and routine blood tests (including PSA levels).
- While on this study the following tests and procedures will be done on months 2 and 4:
review of side effects; routine blood tests (including PSA levels) and urine tests.
- If the patient's disease progressed the treatment code will be broken and if the
patient was on placebo, they will have the option to begin taking rosiglitazone.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.
Matthew Smith, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|