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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Placebo

Placebo Comparator: A -

Active Comparator: B -


Treatment: Drugs: Bicalutamide
150mg p.o. daily

Treatment: Drugs: Placebo
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
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Linz
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Austria
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Mistelbach
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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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Heidelberg
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Jena
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Lubeck
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Ludenscheid
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Mannheim
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Munchen
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Regensburg
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Sigmaringen
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Budapest
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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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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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Italy
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Roma
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Mexico
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Mexico
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Amsterdam
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Breda
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Eindhoven
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Enschede
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Gouda
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Heerlen
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Durban
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George
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Pietermarizberg
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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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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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Essex
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Hertfordshire
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London
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Northern Ireland
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Somerset
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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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United Kingdom
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Bolton
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United Kingdom
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Bristol
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United Kingdom
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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00673205
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00673205