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

Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adenocarcinoma of the Prostate; Prostate Cancer

Intervention: Rosiglitazone (Drug); Placebo (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Matthew Smith, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

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 Details

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome: To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.

Secondary outcome: Evaluate time to PSA progression as a measure of the activity of rosiglitazone.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Additional Information

Starting date: September 2000
Last updated: December 28, 2007

Page last updated: June 20, 2008

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