Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer

This is an open label, single-centered treatment protocol designed to monitor the safety of patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as physician feels that he is benefiting from this form of therapy.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

New York, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Histologically or cytologically confirmed adenocarcinoma of the prostate gland
Patients with advanced prostate cancer
Adult male over the age of 18 years old
Normal liver function (AST < 2 x Upper Limit Normal)

Exclusion criteria

ECOG performance status of 4.
Previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years.

Treatment and study plan

bicalutamide

Drug

200mg daily

Other names: Casodex

Primary outcomes

Safety profile of patients treated with a 200 mg daily dose of CASODEX

Time frame: every three months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Treatment Protocol to Monitor the Safety of a 200 mg Daily Dose of Bicalutamide (Casodex) in Patients With Advanced Prostate Cancer

Important dates

Study start: 1994
Primary completion: 2013
Study completion: 2013
First posted: Feb 19, 2009
Registry last updated: Jan 21, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed