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™)

AstraZeneca1 site in 1 country102 target enrollmentDecember 2003

ConditionsLocally Advanced Prostate Cancer

DrugsIressa

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Locally Advanced Prostate Cancer
Sponsor: AstraZeneca
Enrollment: 102
Locations: 1
Primary Endpoint: Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

August 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

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.

Outcomes

Primary Outcomes

Determine the difference in the rate of PSA decrease between treatments over a 6 months period.

Secondary Outcomes

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