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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
Scientific title
A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
Secondary ID [1] 0 0
7054IL/0024
Secondary ID [2] 0 0
D6876C00024
Universal Trial Number (UTN)
Trial acronym
Capri
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Metastatic Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bicalutamide

Placebo comparator: A -

Active comparator: B -


Treatment: Drugs: Bicalutamide
150mg p.o. daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to clinical progression
Timepoint [1] 0 0
Throughout study period
Primary outcome [2] 0 0
Tolerability in terms of adverse events and laboratory parameters
Timepoint [2] 0 0
Throughout study period
Secondary outcome [1] 0 0
Survival
Timepoint [1] 0 0
Throughout study period
Secondary outcome [2] 0 0
Time to treatment failure
Timepoint [2] 0 0
Throughout study period
Secondary outcome [3] 0 0
Prostate-specific antigen
Timepoint [3] 0 0
Initial study period up to 2005 amended protocol

Eligibility
Key inclusion criteria
* Clinical diagnosis of non-metastatic cancer of the prostate gland
* Patient to be 18 years and above
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/1995
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
Accrual to date
Final
3588
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Wooloongabba
Recruitment hospital [2] 0 0
Research Site - East Melbourne
Recruitment postcode(s) [1] 0 0
- Wooloongabba
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
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Austria
State/province [2] 0 0
Linz
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Austria
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Mistelbach
Country [4] 0 0
Austria
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Oberwart
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Austria
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St. Polten
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Belgium
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Antwerpen
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Mons
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Belgium
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Oostende
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Belgium
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Seraing
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Czech Republic
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Brno
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Czech Republic
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Hradec Kralove
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Czech Republic
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Olomouc
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Czech Republic
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Praha 4
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Czech Republic
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Praha 5
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Freiburg
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Germany
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Heidelberg
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Germany
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Jena
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Germany
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Lubeck
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Germany
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Ludenscheid
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Germany
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Mannheim
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Germany
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Munchen
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Germany
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Regensburg
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Germany
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Sigmaringen
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Hungary
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Budapest
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Hungary
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Miskolc
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Hungary
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Nyiregyhaza
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Ireland
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Dublin 4
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Ireland
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Dublin 7
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Israel
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Haifa
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Israel
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Petach Tikva
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Israel
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Tel-aviv
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Israel
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Tel-hashomer
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Italy
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BA
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Italy
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BG
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Italy
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BL
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Italy
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BO
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Italy
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BS
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Italy
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CO
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Italy
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FO
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Italy
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FR
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Italy
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MO
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Italy
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PR
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Italy
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SI
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Italy
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TO
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Italy
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TV
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Italy
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UD
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Italy
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VA
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Italy
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VE
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Italy
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Roma
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Mexico
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Mexico
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Netherlands
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Amsterdam
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Breda
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Capelle A/d Ijssel
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Eindhoven
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Enschede
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Gouda
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Heerlen
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Maastricht
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Durban
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George
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Pietermarizberg
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South Africa
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Pretoria
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Andalucia
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Asturias
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Spain
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Castilla La Mancha
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Castilla Leon
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Spain
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Cataluna
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Spain
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Comunidad de Madrid
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Navarra
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Spain
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Pais Vasco
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United Kingdom
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Berkshire
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United Kingdom
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Essex
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United Kingdom
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Hertfordshire
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United Kingdom
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London
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United Kingdom
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Northern Ireland
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United Kingdom
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Somerset
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United Kingdom
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South Wales
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United Kingdom
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Sussex
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West Midlands
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Bolton
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United Kingdom
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Bristol
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Cardiff
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Cleveland
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Edinburgh
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Falkirk
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United Kingdom
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Hull
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United Kingdom
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Kent
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United Kingdom
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Leeds
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United Kingdom
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Manchester
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United Kingdom
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Plymouth
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Sheffield
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Shrewsbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Manfred P Wirth, Professor
Address 0 0
Technical University of Dresden, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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