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

Primary Purpose

Non-Metastatic Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bicalutamide
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Metastatic Prostate Cancer focused on measuring androgen antagonists, prostate neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Time to clinical progression
Tolerability in terms of adverse events and laboratory parameters

Secondary Outcome Measures

Survival
Time to treatment failure
Prostate-specific antigen

Full Information

First Posted
May 2, 2008
Last Updated
December 9, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00673205
Brief Title
(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer
Acronym
Capri
Official Title
A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Metastatic Prostate Cancer
Keywords
androgen antagonists, prostate neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3588 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex
Intervention Description
150mg p.o. daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time to clinical progression
Time Frame
Throughout study period
Title
Tolerability in terms of adverse events and laboratory parameters
Time Frame
Throughout study period
Secondary Outcome Measure Information:
Title
Survival
Time Frame
Throughout study period
Title
Time to treatment failure
Time Frame
Throughout study period
Title
Prostate-specific antigen
Time Frame
Initial study period up to 2005 amended protocol

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred P Wirth, Professor
Organizational Affiliation
Technical University of Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Wooloongabba
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
East Melbourne
State/Province
Victoria
Country
Australia
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City
Graz
Country
Austria
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City
Linz
Country
Austria
Facility Name
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City
Mistelbach
Country
Austria
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City
Oberwart
Country
Austria
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City
St. Polten
Country
Austria
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City
Antwerpen
Country
Belgium
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City
Brugge
Country
Belgium
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Brussels
Country
Belgium
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City
Gent
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Belgium
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City
Kortrijk
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Belgium
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City
Leuven
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Belgium
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City
Mons
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Belgium
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City
Oostende
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Belgium
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City
Seraing
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Belgium
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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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City
Praha 4
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Czech Republic
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Praha 5
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Czech Republic
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Berlin
Country
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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Germany
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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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Hungary
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Dublin 4
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Ireland
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Dublin 7
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Ireland
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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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Israel
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Bari
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BA
Country
Italy
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Bergamo
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BG
Country
Italy
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Belluno
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BL
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Italy
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Bologna
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BO
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Italy
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Brescia
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BS
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Italy
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Como
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CO
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Italy
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Cesena
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FO
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Italy
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Anagni
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FR
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Italy
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Carpi
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MO
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Italy
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Fidenza
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PR
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Italy
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Siena
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SI
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Italy
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Torino
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TO
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Italy
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Treviso
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TV
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Italy
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Udine
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UD
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Italy
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Varese
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VA
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Italy
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Dolo
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VE
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Italy
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Portogruaro
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VE
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Italy
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Roma
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Italy
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Mexico
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Mexico
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Amsterdam
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Netherlands
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Breda
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Netherlands
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Capelle A/d Ijssel
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Netherlands
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Eindhoven
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Netherlands
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Enschede
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Netherlands
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Gouda
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Netherlands
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Heerlen
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Netherlands
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Maastricht
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Netherlands
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Nijmegen
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Netherlands
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Roosendaal
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Netherlands
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Rotterdam
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Netherlands
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Spijkenisse
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Netherlands
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Utrecht
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Netherlands
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Warszawa
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Poland
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Wroclaw
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Poland
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Almada
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Vila Nova de Gaia
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Portugal
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Somerset West
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Cape Town
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South Africa
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Bloemfontein
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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George
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South Africa
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Johannesburg
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South Africa
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Pietermarizberg
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South Africa
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Pretoria
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South Africa
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Granada
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Andalucia
Country
Spain
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Malaga
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Andalucia
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Spain
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Sevilla
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Andalucia
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Spain
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Oviedo
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Asturias
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Spain
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Guadalajara
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Castilla La Mancha
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Spain
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Salamanca
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Castilla Leon
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Spain
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Badalona(barcelona)
State/Province
Cataluna
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Spain
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Barcelona
State/Province
Cataluna
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Spain
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Hospitalet de Llobregat(barcel
State/Province
Cataluna
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Spain
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Alcala de Henares
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Comunidad de Madrid
Country
Spain
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Getafe
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Comunidad de Madrid
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Spain
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Madrid
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Comunidad de Madrid
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Spain
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San Juan(alicante)
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Comunidad Valenciana
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Spain
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Valencia
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Comunidad Valenciana
Country
Spain
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A Coruna
State/Province
Galicia
Country
Spain
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Vigo(pontevedra)
State/Province
Galicia
Country
Spain
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Pamplona
State/Province
Navarra
Country
Spain
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Bilbao
State/Province
Pais Vasco
Country
Spain
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City
Reading
State/Province
Berkshire
Country
United Kingdom
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Research Site
City
Colchester
State/Province
Essex
Country
United Kingdom
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Research Site
City
Barnet
State/Province
Hertfordshire
Country
United Kingdom
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Research Site
City
Tooting
State/Province
London
Country
United Kingdom
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Research Site
City
Belfast
State/Province
Northern Ireland
Country
United Kingdom
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Research Site
City
Taunton
State/Province
Somerset
Country
United Kingdom
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Research Site
City
Gwent
State/Province
South Wales
Country
United Kingdom
Facility Name
Research Site
City
Eastbourne
State/Province
Sussex
Country
United Kingdom
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Research Site
City
Birmingham
State/Province
West Midlands
Country
United Kingdom
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Research Site
City
Bolton
Country
United Kingdom
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Research Site
City
Bristol
Country
United Kingdom
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Research Site
City
Cardiff
Country
United Kingdom
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Research Site
City
Cleveland
Country
United Kingdom
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Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Research Site
City
Falkirk
Country
United Kingdom
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City
Hull
Country
United Kingdom
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City
Kent
Country
United Kingdom
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City
Leeds
Country
United Kingdom
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London
Country
United Kingdom
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Research Site
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Manchester
Country
United Kingdom
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Research Site
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Plymouth
Country
United Kingdom
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Research Site
City
Sheffield
Country
United Kingdom
Facility Name
Research Site
City
Shrewsbury
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22129214
Citation
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.
Results Reference
derived

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

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