Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

Phase 2

Completed

• Conditions: Locally Advanced Prostate Cancer

• Registration Number: NCT00319787
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2006-04-27
• Study First Submitted QC: 2006-04-27
• Study First Posted: 2006-04-27
• Study Completion: 2006-08
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 102

Inclusion Criteria

• 18 to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇳🇴 Trondheim, Norway