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

Completed · Phase 3 · Has a placebo group

Conditions studied: Adenocarcinoma of the Prostate, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00182052

Run by

Massachusetts General Hospital

People needed

100

Starts

2000-09-01

Expected to finish

2003-08-01

Last updated by the study team

2013-05-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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