Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer
The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized Placebo Controlled Study to Assess the Rate of PSA Decrease, Anatomical & Metabolic Changes in the Prostate Determined by MRI/3D-MRS & Histological Changes by Biopsy in Subjects With Locally Advanced Prostate Carcinoma Treated With Either Casodex® (Bicalutamide) Alone or the Combination of Casodex® & ZD1839 (Iressa™)|
- Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
- To detect changes in prostatic metabolites by using in vivo magnetic resonance spectroscopy (MRS)
- To detect changes in prostate gland using magnetic resonance imaging (MRI)
- To detect changes in serum tumor markers
- To assess histopathological changes
|Study Start Date:||December 2003|
|Study Completion Date:||August 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319787
|Study Director:||AstraZeneca Norway Medical Director, MD||AstraZeneca AS|