Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

Locally Advanced Prostate Cancer Clinical Trial

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™)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319787
• Other study ID #: 1839IL/0129
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2006
• Last updated: January 24, 2011
• Start date: December 2003
• Est. completion date: August 2006

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Iressa

Locations

Country	Name	City	State
Norway	Research Site	Moelv
Norway	Research Site	Oslo
Norway	Research Site	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
Secondary	To detect changes in prostatic metabolites by using in vivo magnetic resonance spectroscopy (MRS)
Secondary	To detect changes in prostate gland using magnetic resonance imaging (MRI)
Secondary	To detect changes in serum tumor markers
Secondary	To assess histopathological changes