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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00846976
First received: February 18, 2009
Last updated: January 20, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Bicalutamide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Treatment Protocol to Monitor the Safety of a 200 mg Daily Dose of Bicalutamide (Casodex) in Patients With Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety profile of patients treated with a 200 mg daily dose of CASODEX [ Time Frame: every three months ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: December 1994
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 200 mg Casodex Drug: Bicalutamide
200mg daily
Other Name: Casodex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846976

Locations
United States, New York
Research Site
New York, New York, United States
Sponsors and Collaborators
AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00846976     History of Changes
Other Study ID Numbers: D6874C00014
Study First Received: February 18, 2009
Last Updated: January 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Safety

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Androgen Antagonists
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 29, 2015