Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by AstraZeneca.
Recruitment status was Active, not recruiting
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.
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
|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 October 21, 2014
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs