NCT00182052

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Adenocarcinoma of the Prostate
• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2000-09-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2005-09-16
• Last updated: 2013-05-23

Locations

2 sites across 1 country: United States