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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00673205
First received: May 2, 2008
Last updated: December 9, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Metastatic Prostate Cancer
 Drug: Bicalutamide
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to clinical progression [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Prostate-specific antigen [ Time Frame: Initial study period up to 2005 amended protocol ] [ Designated as safety issue: No ]

Enrollment: 3588
Study Start Date: September 1995
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Placebo
Active Comparator: B Drug: Bicalutamide
150mg p.o. daily
Other Name: Casodex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673205

  Show 130 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Manfred P Wirth, Professor Technical University of Dresden, Germany
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Tom Morris, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00673205     History of Changes
Other Study ID Numbers: D6876C00024, 7054IL/0024
Study First Received: May 2, 2008
Last Updated: December 9, 2010
Health Authority: Austria: Agency for Health and Food Safety
Australia: National Health and Medical Research Council
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Directorate general for the protection of Public health: Medicines
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
United Kingdom: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
Hungary: National Institute of Pharmacy
Ireland: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: Ministry of Health
Italy: Ministry of Health
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Ministry of Health
Mexico: National Council of Science and Technology
Mexico: National Institute of Public Health, Health Secretariat
Netherlands: Dutch Health Care Inspectorate
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Portugal: National Pharmacy and Medicines Institute
South Africa: Department of Health
South Africa: Medicines Control Council
Spain: Ministry of Health
Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
androgen antagonists
prostate neoplasms

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
 Bicalutamide
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013