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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00672282 |
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Date of registration:
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02/05/2008 |
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Primary sponsor: |
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Public title:
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Casodex vs Placebo in Non-Metastatic Early Prostate Cancer
SPCG6 |
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Scientific title:
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A Randomized, Double-Blind, Parallel-Group Trial Comparing 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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October 1995 |
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Target sample size:
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1218 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00672282 |
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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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Countries of recruitment
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Denmark
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Finland
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Norway
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Sweden
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Contacts
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Name:
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Peter Iversen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Urology Rigshospitalet Copenhagen, Denmark |
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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: Bicalutamide
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Drug: Placebo
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Primary Outcome(s)
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Survival
[Time Frame: Throughout study period]
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Time to clinical progression
[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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Time to treatment failure
[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 ID(s)
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7054IL/0025
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D6876C00025
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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