Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

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™)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00319787

Enrollment

102

Registered

2006-04-27

Start date

2003-12-31

Completion date

2006-08-31

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Prostate Cancer

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.

Interventions

DRUGIressa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026