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Trial record 1 of 1 for:    NCT00657904
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Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00657904
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.

Condition or disease Intervention/treatment Phase
Non-metastatic Prostate Cancer Drug: Bicalutamide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.
Study Start Date : August 1995
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1 Drug: Bicalutamide
150mg daily
Other Name: Casodex™

Placebo Comparator: 2 Drug: Placebo
once daily




Primary Outcome Measures :
  1. Time to clinical progression [ Time Frame: Throughout study period ]
  2. Overall patient survival [ Time Frame: Throughout study period ]

Secondary Outcome Measures :
  1. Time to treatment failure [ Time Frame: Throughout study period ]
  2. Serum prostate-specific antigen [ Time Frame: Initial study period up to 2006 amended protocol ]
  3. Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate cancer in the early stage of disease
  • Prostate removed and/or radiation therapy to the prostate area

Exclusion Criteria:

  • Previous systemic therapy for prostate cancer
  • Previous history of another form of cancer (not prostate) within 5 years of study start.

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): NCT00657904


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: William See Medical College of Wisconsin
Principal Investigator: David G. McLeod Walter Reed Army Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00657904    
Other Study ID Numbers: D6876C00023
7054IL/0023
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012
Keywords provided by AstraZeneca:
androgen antagonists
prostate neoplasms
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents