(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer (Capri)

December 9, 2010 updated by: AstraZeneca

A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3588

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Wooloongabba, Queensland, Australia
        • Research Site
    • Victoria
      • East Melbourne, Victoria, Australia
        • Research Site
  • Austria
      • Graz, Austria
        • Research Site
      • Linz, Austria
        • Research Site
      • Mistelbach, Austria
        • Research Site
      • Oberwart, Austria
        • Research Site
      • St. Polten, Austria
        • Research Site
  • Belgium
      • Antwerpen, Belgium
        • Research Site
      • Brugge, Belgium
        • Research Site
      • Brussels, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Kortrijk, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Mons, Belgium
        • Research Site
      • Oostende, Belgium
        • Research Site
      • Seraing, Belgium
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Praha 4, Czech Republic
        • Research Site
      • Praha 5, Czech Republic
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Bonn, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Jena, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Ludenscheid, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Sigmaringen, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
  • Ireland
      • Dublin 4, Ireland
        • Research Site
      • Dublin 7, Ireland
        • Research Site
  • Israel
      • Haifa, Israel
        • Research Site
      • Petach Tikva, Israel
        • Research Site
      • Tel-aviv, Israel
        • Research Site
      • Tel-hashomer, Israel
        • Research Site
  • Italy
      • Roma, Italy
        • Research Site
    • BA
      • Bari, BA, Italy
        • Research Site
    • BG
      • Bergamo, BG, Italy
        • Research Site
    • BL
      • Belluno, BL, Italy
        • Research Site
    • BO
      • Bologna, BO, Italy
        • Research Site
    • BS
      • Brescia, BS, Italy
        • Research Site
    • CO
      • Como, CO, Italy
        • Research Site
    • FO
      • Cesena, FO, Italy
        • Research Site
    • FR
      • Anagni, FR, Italy
        • Research Site
    • MO
      • Carpi, MO, Italy
        • Research Site
    • PR
      • Fidenza, PR, Italy
        • Research Site
    • SI
      • Siena, SI, Italy
        • Research Site
    • TO
      • Torino, TO, Italy
        • Research Site
    • TV
      • Treviso, TV, Italy
        • Research Site
    • UD
      • Udine, UD, Italy
        • Research Site
    • VA
      • Varese, VA, Italy
        • Research Site
    • VE
      • Dolo, VE, Italy
        • Research Site
      • Portogruaro, VE, Italy
        • Research Site
  • Mexico
      • Mexico, Mexico
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Breda, Netherlands
        • Research Site
      • Capelle A/d Ijssel, Netherlands
        • Research Site
      • Eindhoven, Netherlands
        • Research Site
      • Enschede, Netherlands
        • Research Site
      • Gouda, Netherlands
        • Research Site
      • Heerlen, Netherlands
        • Research Site
      • Maastricht, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Roosendaal, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Spijkenisse, Netherlands
        • Research Site
      • Utrecht, Netherlands
        • Research Site
  • Poland
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
  • Portugal
      • Almada, Portugal
        • Research Site
      • Coimbra, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Vila Nova de Gaia, Portugal
        • Research Site
  • South Africa
      • Bloemfontein, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • George, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Pietermarizberg, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
    • Cape Town
      • Somerset West, Cape Town, South Africa
        • Research Site
  • Spain
    • Andalucia
      • Granada, Andalucia, Spain
        • Research Site
      • Malaga, Andalucia, Spain
        • Research Site
      • Sevilla, Andalucia, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Castilla La Mancha
      • Guadalajara, Castilla La Mancha, Spain
        • Research Site
    • Castilla Leon
      • Salamanca, Castilla Leon, Spain
        • Research Site
    • Cataluna
      • Badalona(barcelona), Cataluna, Spain
        • Research Site
      • Barcelona, Cataluna, Spain
        • Research Site
      • Hospitalet de Llobregat(barcel, Cataluna, Spain
        • Research Site
    • Comunidad Valenciana
      • San Juan(alicante), Comunidad Valenciana, Spain
        • Research Site
      • Valencia, Comunidad Valenciana, Spain
        • Research Site
    • Comunidad de Madrid
      • Alcala de Henares, Comunidad de Madrid, Spain
        • Research Site
      • Getafe, Comunidad de Madrid, Spain
        • Research Site
      • Madrid, Comunidad de Madrid, Spain
        • Research Site
    • Galicia
      • A Coruna, Galicia, Spain
        • Research Site
      • Vigo(pontevedra), Galicia, Spain
        • Research Site
    • Navarra
      • Pamplona, Navarra, Spain
        • Research Site
    • Pais Vasco
      • Bilbao, Pais Vasco, Spain
        • Research Site
  • United Kingdom
      • Bolton, United Kingdom
        • Research Site
      • Bristol, United Kingdom
        • Research Site
      • Cardiff, United Kingdom
        • Research Site
      • Cleveland, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
      • Falkirk, United Kingdom
        • Research Site
      • Hull, United Kingdom
        • Research Site
      • Kent, United Kingdom
        • Research Site
      • Leeds, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Plymouth, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Shrewsbury, United Kingdom
        • Research Site
    • Berkshire
      • Reading, Berkshire, United Kingdom
        • Research Site
    • Essex
      • Colchester, Essex, United Kingdom
        • Research Site
    • Hertfordshire
      • Barnet, Hertfordshire, United Kingdom
        • Research Site
    • London
      • Tooting, London, United Kingdom
        • Research Site
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom
        • Research Site
    • Somerset
      • Taunton, Somerset, United Kingdom
        • Research Site
    • South Wales
      • Gwent, South Wales, United Kingdom
        • Research Site
    • Sussex
      • Eastbourne, Sussex, United Kingdom
        • Research Site
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: Bicalutamide
150mg p.o. daily
Other Names:
  • Casodex
Placebo Comparator: A
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to clinical progression
Time Frame: Throughout study period
Throughout study period
Tolerability in terms of adverse events and laboratory parameters
Time Frame: Throughout study period
Throughout study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to treatment failure
Time Frame: Throughout study period
Throughout study period
Survival
Time Frame: Throughout study period
Throughout study period
Prostate-specific antigen
Time Frame: Initial study period up to 2005 amended protocol
Initial study period up to 2005 amended protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Manfred P Wirth, Professor, Technical University of Dresden, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1995

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 9, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6876C00024
  • 7054IL/0024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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