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OpenTrials
Completed

NCT Number: NCT00657904

Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

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.

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Key information

Conditions

Non-Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bicalutamide

Drug

150mg daily

Other names: Casodex™

Placebo

Drug

once daily

Primary outcomes

  1. Time to clinical progression

    Time frame: Throughout study period

  2. Overall patient survival

    Time frame: Throughout study period

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.

Important dates

Study start
1995
Primary completion
2008
Study completion
2008
First posted
Apr 14, 2008
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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