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Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00319787
First Posted: April 27, 2006
Last Update Posted: January 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Locally Advanced Prostate Cancer Drug: Iressa Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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™)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 102
Study Start Date: December 2003
Study Completion Date: August 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319787


Locations
Norway
Research Site
Moelv, Norway
Research Site
Oslo, Norway
Research Site
Trondheim, Norway
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Norway Medical Director, MD AstraZeneca AS
  More Information

ClinicalTrials.gov Identifier: NCT00319787     History of Changes
Other Study ID Numbers: 1839IL/0129
First Submitted: April 27, 2006
First Posted: April 27, 2006
Last Update Posted: January 25, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Gefitinib
Bicalutamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs