Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: February 18, 2009
Last updated: September 24, 2012
Last verified: September 2012
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Treatment Protocol to Monitor the Safety of a 200 mg Daily Dose of Bicalutamide (Casodex) in Patients With Advanced Prostate Cancer
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
Other Name: Casodex
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00846976
|New York, New York, United States |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 18, 2009
||September 24, 2012
||United States: Food and Drug Administration
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs