Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer
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™)
1 other identifier
interventional
102
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2003
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 27, 2006
CompletedFirst Posted
Study publicly available on registry
April 27, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedJanuary 25, 2011
January 1, 2011
April 27, 2006
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Moelv, Norway
Research Site
Oslo, Norway
Research Site
Trondheim, Norway
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Norway Medical Director, MD
AstraZeneca AS
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 27, 2006
First Posted
April 27, 2006
Study Start
December 1, 2003
Study Completion
August 1, 2006
Last Updated
January 25, 2011
Record last verified: 2011-01