Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00319787
First received: April 27, 2006
Last updated: January 24, 2011
Last verified: January 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00319787     History of Changes
Other Study ID Numbers: 1839IL/0129
Study First Received: April 27, 2006
Last Updated: January 24, 2011
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014