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(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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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
MedlinePlus 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 ]
- Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ]
Secondary Outcome Measures:
- Survival [ Time Frame: Throughout study period ]
- Time to treatment failure [ Time Frame: Throughout study period ]
- Prostate-specific antigen [ Time Frame: Initial study period up to 2005 amended protocol ]
| 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) |
| Sexes 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
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 |
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 June 23, 2017