(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer
Capri
A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
2 other identifiers
interventional
3,588
15 countries
123
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 1995
Longer than P75 for phase_3
123 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1995
CompletedFirst Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedDecember 10, 2010
December 1, 2010
12.9 years
May 2, 2008
December 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to clinical progression
Throughout study period
Tolerability in terms of adverse events and laboratory parameters
Throughout study period
Secondary Outcomes (3)
Survival
Throughout study period
Time to treatment failure
Throughout study period
Prostate-specific antigen
Initial study period up to 2005 amended protocol
Study Arms (2)
A
PLACEBO COMPARATORB
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of non-metastatic cancer of the prostate gland
- Patient to be 18 years and above
You may not qualify if:
- Previous systemic therapy for prostate cancer
- Previous history of another form of cancer (not prostate) within 5 years of study start.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (128)
Research Site
Wooloongabba, Queensland, Australia
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East Melbourne, Victoria, Australia
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Graz, Austria
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Linz, Austria
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Mistelbach, Austria
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Oberwart, Austria
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Sankt Pölten, Austria
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Antwerp, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Mons, Belgium
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Ostend, Belgium
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Seraing, Belgium
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Brno, Czechia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Berlin, Germany
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Bonn, Germany
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Dresden, Germany
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Freiburg im Breisgau, Germany
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Heidelberg, Germany
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Jena, Germany
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Lübeck, Germany
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Lüdenscheid, Germany
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Mannheim, Germany
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München, Germany
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Regensburg, Germany
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Sigmaringen, Germany
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Budapest, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
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Dublin, Ireland
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Haifa, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Bari, BA, Italy
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Bergamo, BG, Italy
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Belluno, BL, Italy
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Bologna, BO, Italy
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Brescia, BS, Italy
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Como, CO, Italy
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Cesena, FO, Italy
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Anagni, FR, Italy
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Carpi, MO, Italy
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Fidenza, PR, Italy
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Roma, Roma, Italy
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Siena, SI, Italy
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Torino, TO, Italy
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Treviso, TV, Italy
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Udine, UD, Italy
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Varese, VA, Italy
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Dolo, VE, Italy
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Portogruaro, VE, Italy
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México, Mexico
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Amsterdam, Netherlands
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Breda, Netherlands
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Capelle aan den IJssel, Netherlands
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Eindhoven, Netherlands
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Enschede, Netherlands
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Gouda, Netherlands
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Heerlen, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Roosendaal, Netherlands
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Rotterdam, Netherlands
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Spijkenisse, Netherlands
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Utrecht, Netherlands
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Warsaw, Poland
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Wroclaw, Poland
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Almada, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Vila Nova de Gaia, Portugal
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Somerset West, Cape Town, South Africa
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Bloemfontein, South Africa, South Africa
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Cape Town, South Africa
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Durban, South Africa
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George, South Africa
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Johannesburg, South Africa
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Pietermarizberg, South Africa
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Pretoria, South Africa
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Granada, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Bilbao, Basque Country, Spain
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Salamanca, Castille and León, Spain
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Guadalajara, Castille-La Mancha, Spain
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Badalona(barcelona), Catalonia, Spain
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Barcelona, Catalonia, Spain
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Hospitalet de Llobregat(barcel, Catalonia, Spain
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A Coruña, Galicia, Spain
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Vigo(pontevedra), Galicia, Spain
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Alcalá de Henares, Madrid, Spain
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Getafe, Madrid, Spain
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Madrid, Madrid, Spain
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Pamplona, Navarre, Spain
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Oviedo, Principality of Asturias, Spain
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San Juan(alicante), Valencia, Spain
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Valencia, Valencia, Spain
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Reading, Berkshire, United Kingdom
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Colchester, Essex, United Kingdom
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Barnet, Hertfordshire, United Kingdom
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Tooting, London, United Kingdom
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Belfast, Northern Ireland, United Kingdom
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Taunton, Somerset, United Kingdom
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Gwent, South Wales, United Kingdom
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Eastbourne, Sussex, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Bolton, United Kingdom
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Bristol, United Kingdom
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Cardiff, United Kingdom
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Cleveland, United Kingdom
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Edinburgh, United Kingdom
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Falkirk, United Kingdom
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Hull, United Kingdom
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Kent, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Plymouth, United Kingdom
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Sheffield, United Kingdom
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Shrewsbury, United Kingdom
Related Publications (1)
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.
PMID: 22129214DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred P Wirth, Professor
Technical University of Dresden, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2008
First Posted
May 7, 2008
Study Start
September 1, 1995
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
December 10, 2010
Record last verified: 2010-12