Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

Phase 2CompletedNCT00319787

AstraZeneca102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

102

Conditions

Locally Advanced Prostate Cancer

Interventions

IressaDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (3)

Research Site

Moelv, Norway

Research Site

Oslo, Norway

Research Site

Trondheim, Norway

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

Data from ClinicalTrials.gov

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