(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer (Capri)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00673205
First received: May 2, 2008
Last updated: December 9, 2010
Last verified: December 2010
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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:
Genetics Home Reference related topics:
prostate cancer
Drug Information available for:
Bicalutamide
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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00673205
Show 130 Study 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
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: Federal Agency for Medicines and Health Products, FAMHP 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 |
Bicalutamide Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 29, 2016