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

NCT ID: NCT00846976

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-12-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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200 mg Casodex

Group Type EXPERIMENTAL

Bicalutamide

Intervention Type DRUG

200mg daily

Interventions

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Bicalutamide

200mg daily

Intervention Type DRUG

Other Intervention Names

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Casodex

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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D6874C00014

Identifier Type: -

Identifier Source: org_study_id

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