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
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