A Double Blinded Randomized Crossover Phase III Study of Oral Thalidomide Versus Placebo in Patients With Stage D0 Androgen Dependent Prostate Cancer Following Limited Hormonal Ablation
This is a double-blind randomized phase III study designed to determine if thalidomide can
improve the efficacy of the luteinizing hormone releasing hormone (LHRH) agonist (leuprolide
or goserelin) in hormone-responsive patients with a rising PSA after primary definitive
therapy for prostate cancer. Patients with only a rising PSA will be randomized to LHRH
agonist for six months followed by oral thalidomide 200 mg per day or placebo (phase A). At
the time of PSA progression, an LHRH agonist will be restarted for six additional months.
After six months, patients originally treated with thalidomide will be crossed over to
placebo and patients originally treated with placebo will be crossed over to thalidomide and
followed until PSA progression or the development of metastatic disease, whichever occurs
first (Phase B). Additional information will be obtained on changes in the circulating
levels of the following growth factors: basic fibroblast growth factor (bFGF), tumor
necrosis factor (TNF), vascular endothelial growth factor (VEGF), and transforming growth
factor beta (TGFbeta). Likewise we will monitor changes in testosterone and
dihydrotestosterone (DHT) throughout the study. Neurological complications are the primary
dose-limiting toxicity anticipated with chronic thalidomide administration.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time to Progression
Time to progression is defined as follows: if the PSA returns to baseline (defined as the PSA value prior to starting leuprolide or goserelin) or increases to the absolute value of 5 ng/ml.
William L Dahut, M.D.
National Cancer Institute, National Institutes of Heath
United States: Federal Government
|Louisiana State University||New Orleans, Louisiana 70112-2282|
|Naval Medical Center, Portsmouth||Portsmouth, Virginia 23708-2197|
|University of Minnesota||Minneapolis, Minnesota 55455|
|University of Washington||Seattle, Washington 98195|
|Holy Cross Hospital, Fort Lauderdale||Fort Lauderdale, Florida 33308|
|Wayne State University Hutzel Hospital||Detroit, Michigan 48201|
|Columbia University||New York, New York 10032-3784|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|National Institutes of Health, Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|