Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study

Conditions
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Adenocarcinoma of the Prostate, Prostate Cancer

Intervention / Treatment
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* Drug: Rosiglitazone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Biochemical disease progression following local therapy defined as three rises in PSA with each PSA determination at least 4 weeks apart and each PSA value > or = 0.2ng/ml For men treated with radical prostatectomy, PSA > or = 2 ng/ml For men treated with primary radiation therapy or post-prostatectomy radiation therapy, PSA > or = 2 ng/ml and > 150% post-radiation nadir Not an appropriate candidate for salvage radiation therapy or salvage prostatectomy Baseline PSADT < 24 months CALGB performance status of 0,1 or 2 Exclusion Criteria: Metastatic disease Prior hormonal therapy for recurrent prostate cancer Prior chemotherapy for prostate cancer Current treatment with insulin or an oral hypoglycemic History of treatment with thiazolidinediones Radiation therapy within 6 months SGOT > 1.5 x ULN Fasting blood glucose < 60 mg/dl NYHA Class 3 or 4 cardiac status

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Drug: Rosiglitazone<br>* 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.<br>* Other names: Avandia;|
| Placebo Comparator: Group 2<br> | Other: Placebo<br>* Given orally twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate time to PSA progression as a measure of the activity of rosiglitazone. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosiglitazone, Avandia, androgen dependant prostate cancer