Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on patients and their prostate cancer. This study is going to look at what effects rosiglitazone has on prostate specific antigen (PSA) levels.
Adenocarcinoma of the Prostate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study|
- To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Evaluate time to PSA progression as a measure of the activity of rosiglitazone. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2000|
|Study Completion Date:||August 2003|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
|Active Comparator: Group 1||
Given orally twice daily. Participants may continue study treatment as long as their disease does not progress and they don't experience any serious side effects.
Other Name: Avandia
|Placebo Comparator: Group 2||
Given orally twice daily.
- 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 the medication.
- 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.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Matthew Smith, MD||Massachusetts General Hospital|