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OpenTrials
Completed

NCT Number: NCT00319787

Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

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.

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Key information

Conditions

Locally Advanced Prostate Cancer

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Moelv, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iressa

Drug

Primary outcomes

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

Secondary outcomes

  1. To detect changes in prostatic metabolites by using in vivo magnetic resonance spectroscopy (MRS)

  2. To detect changes in prostate gland using magnetic resonance imaging (MRI)

  3. To detect changes in serum tumor markers

  4. To assess histopathological changes

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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™)

Important dates

Study start
2003
Study completion
2006
First posted
Apr 27, 2006
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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