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

Study identifier:D6876C00024

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Non-metastatic prostate cancer

Phase

Phase 3

Healthy volunteers

Study drug

Bicalutamide, Placebo

Sex

Male

Actual Enrollment

3588

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Sept 1995

Primary Completion Date: 01 Aug 2008

Study Completion Date: 01 Aug 2008

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

115

Location

Research Site

EAST MELBOURNE, VIC, Australia

Location

Research Site

WOOLOONGABBA, QLD, Australia

Location

Research Site

GRAZ, Austria

Location

Research Site

LINZ, Austria

Location

Research Site

MISTELBACH, Austria

Location

Research Site

OBERWART, Austria

Location

Research Site

ST. POLTEN, Austria

Location

Research Site

ANTWERPEN, Belgium

Arms	Assigned Interventions
Placebo Comparator: A	-
Active Comparator: B	Drug: Bicalutamide 150mg p.o. daily Other Name: Casodex

Documents available

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https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf
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CSR-7054il0024summary1999.pdf
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CSR-7054il0024summary2001.pdf
Download
CSR-7054il0024summary2003.pdf
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https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf
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https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf
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CSR-D6876C00024.pdf
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Manfred P Wirth

Technical University of Dresden, Germany

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-7054il0024summary1999.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-7054il0024summary2001.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-7054il0024summary2003.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf

CSR-7054il0024summary1999.pdf

CSR-7054il0024summary2001.pdf

CSR-7054il0024summary2003.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=584&filename=CSR-D6876C00024.pdf

CSR-D6876C00024.pdf

Trial Results Summaries