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

Phase 3

Completed

• Conditions: Adenocarcinoma of the Prostate; Prostate Cancer
• Interventions: Other: Placebo; Drug: Rosiglitazone

• Registration Number: NCT00182052
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 2	Placebo	-
Group 1	Rosiglitazone	-

Primary Outcome Measures

Name	Time	Method
To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.	3 years

Secondary Outcome Measures

Name	Time	Method
Evaluate time to PSA progression as a measure of the activity of rosiglitazone.	3 years

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States