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™)
18 Years
80 Years
Male
Locally Advanced Prostate Cancer
Trial Information
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™)
Inclusion Criteria:
- 18 to 80 years of age. Men with histologically confirmed locally advanced prostatic
adenocarcinoma
Exclusion Criteria:
- No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy
or thermotherapy. No abnormal laboratory values. No co-existing malignancies and any
other significant clinical disorder or laboratory finding.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
Principal Investigator
AstraZeneca Norway Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca AS
Authority:
Norway: Norwegian Medicines Agency
Study ID:
1839IL/0129
NCT ID:
NCT00319787
Start Date:
December 2003
Completion Date:
August 2006
Related Keywords:
- Locally Advanced Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|
