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A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Non-Metastatic Prostate Cancer

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Trial Information

A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer


Inclusion Criteria:



- Clinical diagnosis of non-metastatic cancer of the prostate gland

- Patient to be 18 years and above

Exclusion Criteria:

- Previous systemic therapy for prostate cancer

- Previous history of another form of cancer (not prostate) within 5 years of study
start.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to clinical progression

Outcome Time Frame:

Throughout study period

Safety Issue:

No

Principal Investigator

Manfred P Wirth, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Technical University of Dresden, Germany

Authority:

Austria: Agency for Health and Food Safety

Study ID:

D6876C00024

NCT ID:

NCT00673205

Start Date:

September 1995

Completion Date:

August 2008

Related Keywords:

  • Non-Metastatic Prostate Cancer
  • androgen antagonists
  • prostate neoplasms
  • Prostatic Neoplasms

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