A Treatment Protocol to Monitor the Safety of a 200 mg Daily Dose of Bicalutamide (Casodex) in Patients With Advanced Prostate Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Treatment Protocol to Monitor the Safety of a 200 mg Daily Dose of Bicalutamide (Casodex) in Patients With Advanced Prostate Cancer
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety profile of patients treated with a 200 mg daily dose of CASODEX
Outcome Time Frame:
every three months
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
D6874C00014
NCT ID:
NCT00846976
Start Date:
December 1994
Completion Date:
June 2013
Related Keywords:
- Prostate Cancer
- Safety
- Prostatic Neoplasms
Name | Location |
|---|---|
| Research Site | Albany, New York |
