Back to resultsCombination Casodex® and Iressa™ in Locally Advanced Prostate Cancer
Primary Purpose
Locally Advanced Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Iressa
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Prostate Cancer
Eligibility Criteria
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.
Sites / Locations
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00319787
Brief Title
Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer
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™)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
102 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iressa
Primary Outcome Measure Information:
Title
Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
Secondary Outcome Measure Information:
Title
To detect changes in prostatic metabolites by using in vivo magnetic resonance spectroscopy (MRS)
Title
To detect changes in prostate gland using magnetic resonance imaging (MRI)
Title
To detect changes in serum tumor markers
Title
To assess histopathological changes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Norway Medical Director, MD
Organizational Affiliation
AstraZeneca AS
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Moelv
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer
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