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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: August 2003

- 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.

Intervention(s) in this Clinical Trial

• Drug: Rosiglitazone
  • 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: Placebo
  • Given orally twice daily.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Group 1
• Placebo Comparator: Group 2

Primary Measures

• To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.
  • Time Frame: 3 years
    Safety Issue?: No

Secondary Measures

• Evaluate time to PSA progression as a measure of the activity of rosiglitazone.
  • Time Frame: 3 years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Massachusetts General Hospital

Overall Clinical Trial Officials and Contacts

Matthew Smith, MD Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00182052

Study ID Number: 00-100

ClinicalTrials.gov Identifier: NCT00182052

Health Authority: United States: Food and Drug Administration