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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00673205
First Posted: May 7, 2008
Last Update Posted: December 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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: 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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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


  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
First Submitted: May 2, 2008
First Posted: May 7, 2008
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