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

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Dana-Farber Cancer Institute
• Treatments: Androgens; Rosiglitazone

Criteria

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