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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
Open (Enrolling)
Male
Prostate Cancer

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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 SiteAlbany, New York