The Journal of Urology
Volume 181, Issue 3 , Pages 1104-1113 , March 2009

A Double-Blind Randomized Crossover Study of Oral Thalidomide Versus Placebo for Androgen Dependent Prostate Cancer Treated With Intermittent Androgen Ablation

  • William D. Figg

      Affiliations

    • Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
    • Molecular Pharmacology Section, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
    • Corresponding Author InformationCorrespondence: Medical Oncology Branch, National Cancer Institute, Bldg 10/Room 5A01, 9000 Rockville Pike, Bethesda, Maryland 20892 (telephone: 301-402-3623; FAX: 301-402-8606)
    • ,
  • Maha H. Hussain

      Affiliations

    • Departments of Internal Medicine and Urology, University of Michigan Medical Center, Ann Arbor, and Department of Medical Oncology, Wayne State University/Barbara Ann Karmanos Cancer Institute, Detroit, Michigan
    • ,
  • James L. Gulley

      Affiliations

    • Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
    • ,
  • Philip M. Arlen

      Affiliations

    • Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
    • Financial interest and/or other relationship with Neogenix Oncology Inc.
    • ,
  • Jeanny B. Aragon-Ching

      Affiliations

    • Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
    • ,
  • Daniel P. Petrylak

      Affiliations

    • Department of Medicine, New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York
    • ,
  • Celestia S. Higano

      Affiliations

    • Departments of Medicine and Urology, University of Washington, Seattle, Washington
    • ,
  • Seth M. Steinberg

      Affiliations

    • Biostatistics and Data Management Section, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
    • ,
  • Gurkamal S. Chatta

      Affiliations

    • Department of Medicine, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania
    • ,
  • Howard Parnes

      Affiliations

    • Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
    • ,
  • John J. Wright

      Affiliations

    • Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
    • ,
  • Oliver Sartor

      Affiliations

    • Tulane Medical School, New Orleans, Louisiana
    • ,
  • William L. Dahut

      Affiliations

    • Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland

Received 26 August 2008

  • Image Result

    Schema for randomized, crossover, placebo controlled, phase III trial following limited androgen deprivation therapy

    Schema for randomized, crossover, placebo controlled, phase III trial following limited androgen deprivation therapy

  • Image Result

    CONSORT diagram for OPA

    CONSORT diagram for OPA

  • Image Result

    CONSORT diagram for OPB. Asterisk indicates that patients listed as still on study were on study at time of analysis

    CONSORT diagram for OPB. Asterisk indicates that patients listed as still on study were on study at time of analysis

  • Image Result

    A, Kaplan-Meier graph showing times to PSA based progression between thalidomide (circle) and placebo (asterisk) during OPA. Median time for thalidomide was 15 months compared to 9.6 months for placeb

    A, Kaplan-Meier graph showing times to PSA based progression between thalidomide (circle) and placebo (asterisk) during OPA. Median time for thalidomide was 15 months compared to 9.6 months for placebo, p = 0.21. B, Kaplan-Meier graph showing times to PSA based progression between thalidomide (circle) and placebo (asterisk) during OPB. Median time for thalidomide was 17.1 months vs 6.6 for placebo, p = 0.0002.

 Supported by the Intramural Research Program of the National Institutes of Health, NCI, Center for Cancer Research.

 Study received institutional review board approval.

 Clinical Trials identifier NCT00020085 (www.clinicaltrials.gov).

 For other articles on related topics see pages 1361, 1372 and 1381.

PII: S0022-5347(08)03053-X

doi: 10.1016/j.juro.2008.11.026

The Journal of Urology
Volume 181, Issue 3 , Pages 1104-1113 , March 2009

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