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

Prostate Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

• 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00182052
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 3
• Start date: September 2000
• Completion date: August 2003