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Related Experiment Videos

The bicalutamide Early Prostate Cancer Program. Demography.

W A. See1, D McLeod, P Iversen

  • 1Division of Urology, Medical College of Wisconsin, 9200 W. Wisconsin Avenue, 53226, Milwaukee, WI, USA

Urologic Oncology
|February 13, 2001
PubMed
Summary

Bicalutamide is being investigated as a treatment for early prostate cancer in a large clinical trial. This study will provide key data on its effectiveness and role in patient care.

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Area of Science:

  • Oncology
  • Urology
  • Clinical Trials

Background:

  • Optimal treatment for early prostate cancer remains under investigation.
  • Bicalutamide, a well-tolerated hormonal therapy, is a potential option for early prostate cancer, either as adjuvant or immediate treatment.
  • A large collaborative clinical trials program was established to evaluate bicalutamide for localized and locally advanced prostate cancer.

Purpose of the Study:

  • To investigate the efficacy and tolerability of bicalutamide in men with early prostate cancer.
  • To determine the role of bicalutamide as an adjunct to standard care or watchful waiting in prostate cancer management.

Main Methods:

  • The Bicalutamide Early Prostate Cancer program involved three randomized, double-blind, placebo-controlled trials.

Related Experiment Videos

  • 8113 men with T1b-4N0-1M0 (TNM 1997) prostate cancer were randomized 1:1 to receive bicalutamide 150 mg daily or placebo.
  • Study endpoints included time to clinical progression, overall survival, and tolerability, with ongoing follow-up.

    • Main Results:

    • The study enrolled 8113 men aged 38-93 years over three years.
    • The majority of patients had localized disease (T1-2) with Gleason score ≤6 and node-negative status.
    • 71.8% of patients received primary curative intent therapy within 16 weeks; the rest underwent watchful waiting.

    Conclusions:

    • This represents the largest randomized clinical trial program to date for early prostate cancer.
    • The program is expected to yield critical data on bicalutamide's role in managing early prostate cancer.
    • Findings will inform the use of bicalutamide as an addition to standard care or watchful waiting strategies.