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...
Date First Received: May 2, 2008
Last Updated: May 26, 2009
Verified by: AstraZeneca, March 2009
Clinical Trial Phase: Phase 3 | Start Date: October 1995
Overall Status: Completed
Estimated Enrollment: 1218
Brief Summary
Official Title: “A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Bicalutamide
- 150mg p.o. daily
- Drug: Placebo
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: A
- Active Comparator: B
Outcome Measures for this Clinical Trial
Primary Measures
- Survival
- Time Frame: Throughout study period
Safety Issue?: No
- Time Frame: Throughout study period
- Time to clinical progression
- Time Frame: Throughout study period
Safety Issue?: No
- Time Frame: Throughout study period
Secondary Measures
- Tolerability in terms of adverse events and laboratory parameters
- Time Frame: Throughout study period
Safety Issue?: Yes
- Time Frame: Throughout study period
- Time to treatment failure
- Time Frame: Throughout study period
Safety Issue?: No
- Time Frame: Throughout study period
- Prostate-specific antigen
- Time Frame: Initial study period up to 2005 amended protocol
Safety Issue?: No
- Time Frame: Initial study period up to 2005 amended protocol
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Peter Iversen, MD Principal Investigator Department of Urology Rigshospitalet Copenhagen, Denmark
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00672282
Study ID Number: D6876C00025
ClinicalTrials.gov Identifier: NCT00672282
Health Authority: Denmark: Danish Dataprotection Agency
Clinical Trials Authorship and Review
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