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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00673205 |
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Date of registration:
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02/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer
Capri |
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Scientific title:
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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 |
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Date of first enrolment:
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September 1995 |
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Target sample size:
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3588 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00673205 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Austria
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Belgium
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Czech Republic
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Germany
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Hungary
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Ireland
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Israel
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Italy
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Mexico
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Netherlands
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Poland
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Portugal
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South Africa
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Spain
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United Kingdom
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Contacts
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Name:
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Manfred P Wirth, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Technical University of Dresden, Germany |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Non-Metastatic Prostate Cancer
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Intervention(s)
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Drug: Placebo
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Drug: Bicalutamide
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Primary Outcome(s)
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Time to clinical progression
[Time Frame: Throughout study period]
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Tolerability in terms of adverse events and laboratory parameters
[Time Frame: Throughout study period]
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Secondary Outcome(s)
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Prostate-specific antigen
[Time Frame: Initial study period up to 2005 amended protocol]
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Survival
[Time Frame: Throughout study period]
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Time to treatment failure
[Time Frame: Throughout study period]
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Secondary ID(s)
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D6876C00024
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7054IL/0024
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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