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

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ClinicalTrials.gov Identifier: NCT00673205
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Non-Metastatic Prostate Cancer Drug: Bicalutamide Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : September 1995
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: A Drug: Placebo
Active Comparator: B Drug: Bicalutamide
150mg p.o. daily
Other Name: Casodex


Outcome Measures
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Primary Outcome Measures :
  1. Time to clinical progression [ Time Frame: Throughout study period ]
  2. Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: Throughout study period ]
  2. Time to treatment failure [ Time Frame: Throughout study period ]
  3. Prostate-specific antigen [ Time Frame: Initial study period up to 2005 amended protocol ]

Eligibility Criteria
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Information from the National Library of Medicine

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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673205


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Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Manfred P Wirth, Professor Technical University of Dresden, Germany
More Information
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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
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 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