Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00182052|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Prostate Cancer||Drug: Rosiglitazone Other: Placebo||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study|
|Study Start Date :||September 2000|
|Primary Completion Date :||August 2003|
|Study Completion Date :||August 2003|
|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.
- To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men. [ Time Frame: 3 years ]
- Evaluate time to PSA progression as a measure of the activity of rosiglitazone. [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182052
|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|