Trial | NCT00673205  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Non-Metastatic Prostate Cancer

  • Intervention/Treatment

    bicalutamide ...

  • Study Participants

    3588
The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.
Study Started
Sep 30
1995
Primary Completion
Aug 31
2008
Study Completion
Aug 31
2008
Last Update
Dec 10
2010
Estimate

Drug Bicalutamide

150mg p.o. daily

  • Other names: Casodex

Drug Placebo

A Placebo Comparator

B Active Comparator

Criteria 

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.
No Results Posted