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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00673205
Registration number
NCT00673205
Ethics application status
Date submitted
2/05/2008
Date registered
7/05/2008
Date last updated
10/12/2010
Titles & IDs
Public title
(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer
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Scientific title
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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Secondary ID [1]
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7054IL/0024
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Secondary ID [2]
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D6876C00024
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Universal Trial Number (UTN)
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Trial acronym
Capri
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Metastatic Prostate Cancer
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Condition category
Condition code
Cancer
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bicalutamide
Placebo comparator: A -
Active comparator: B -
Treatment: Drugs: Bicalutamide
150mg p.o. daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to clinical progression
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Assessment method [1]
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Timepoint [1]
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Throughout study period
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Primary outcome [2]
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Tolerability in terms of adverse events and laboratory parameters
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [1]
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Survival
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Time to treatment failure
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Prostate-specific antigen
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Assessment method [3]
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Timepoint [3]
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Initial study period up to 2005 amended protocol
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Eligibility
Key inclusion criteria
* Clinical diagnosis of non-metastatic cancer of the prostate gland
* Patient to be 18 years and above
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/1995
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2008
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Sample size
Target
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Accrual to date
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Final
3588
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Research Site - Wooloongabba
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Recruitment hospital [2]
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Research Site - East Melbourne
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- Wooloongabba
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Recruitment postcode(s) [2]
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- East Melbourne
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Austria
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Graz
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00673205
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Trial related presentations / publications
Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010 Apr;105(8):1074-81. doi: 10.1111/j.1464-410X.2010.09319.x.
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Public notes
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Contacts
Principal investigator
Name
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Manfred P Wirth, Professor
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Address
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Technical University of Dresden, Germany
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00673205
Download to PDF