(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:
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
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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.
For general information, see Learn About Clinical Studies.
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
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: 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 Diseases, Male Genital Neoplasms, Male Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Neoplasms Bicalutamide |
Androgen Antagonists Antineoplastic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015