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

References 

  1. Han M, Partin AW, Pound CR, Epstein JI, Walsh PC. Long-term biochemical disease-free and cancer-specific survival following anatomic radical retropubic prostatectomy (The 15-year Johns Hopkins experience). Urol Clin North Am. 2001;28:555
  2. Zietman AL, Coen JJ, Dallow KC, Shipley WU. The treatment of prostate cancer by conventional radiation therapy: an analysis of long-term outcome. Int J Radiat Oncol Biol Phys. 1995;32:287
  3. Han M, Partin AW, Piantadosi S, Epstein JI, Walsh PC. Era specific biochemical recurrence-free survival following radical prostatectomy for clinically localized prostate cancer. J Urol. 2001;166:416
  4. Freedland SJ, Humphreys EB, Mangold LA, Eisenberger M, Dorey FJ, Walsh PC, et al. Risk of prostate cancer-specific mortality following biochemical recurrence after radical prostatectomy. JAMA. 2005;294:433
  5. Loblaw DA, Virgo KS, Nam R, Somerfield MR, Ben-Josef E, Mendelson DS, et al. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol. 2007;25:1596
  6. Wakui S, Furusato M, Itoh T, Sasaki H, Akiyama A, Kinoshita I, et al. Tumour angiogenesis in prostatic carcinoma with and without bone marrow metastasis: a morphometric study. J Pathol. 1992;168:257
  7. Weidner N, Carroll PR, Flax J, Blumenfeld W, Folkman J. Tumor angiogenesis correlates with metastasis in invasive prostate carcinoma. Am J Pathol. 1993;143:401
  8. Figg WD, Dahut W, Duray P, Hamilton M, Tompkins A, Steinberg SM, et al. A randomized phase II trial of thalidomide, an angiogenesis inhibitor, in patients with androgen-independent prostate cancer. Clin Cancer Res. 2001;7:1888
  9. Dahut WL, Gulley JL, Arlen PM, Liu Y, Fedenko KM, Steinberg SM, et al. Randomized phase II trial of docetaxel plus thalidomide in androgen-independent prostate cancer. J Clin Oncol. 2004;22:2532
  10. Boccon-Gibod L, Hammerer P, Madersbacher S, Mottet N, Prayer-Galetti T, Tunn U. The role of intermittent androgen deprivation in prostate cancer. BJU Int. 2007;100:738
  11. Smith MR, Kabbinavar F, Saad F, Hussain A, Gittelman MC, Bilhartz DL, et al. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol. 2005;23:2918
  12. Figg WD, Raje S, Bauer KS, Tompkins A, Venzon D, Bergan R, et al. Pharmacokinetics of thalidomide in an elderly prostate cancer population. J Pharm Sci. 1999;88:121
  13. Gulley JL, Figg WD, Steinberg SM, Carter J, Sartor O, Higano CS, et al. A prospective analysis of the time to normalization of serum androgens following 6 months of androgen deprivation therapy in patients on a randomized phase III clinical trial using limited hormonal therapy. J Urol. 2005;173:1567
  14. Gulley JL, Aragon-Ching JB, Steinberg SM, Hussain MH, Sartor O, Higano CS, et al. Kinetics of serum androgen normalization and factors associated with testosterone reserve after limited androgen deprivation therapy for nonmetastatic prostate cancer. J Urol. 2008;180:1432
  15. Figg WD, Retter A, Steinberg SM, Dahut WL. In reply. J Clin Oncol. 2005;23:2113
  16. Walsh PC, DeWeese TL, Eisenberger MA. A structured debate: immediate versus deferred androgen suppression in prostate cancer–evidence for deferred treatment. J Urol. 2001;166:508
  17. Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, et al. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997;337:295
  18. Immediate versus deferred treatment for advanced prostatic cancer: initial results of the Medical Research Council Trial. The Medical Research Council Prostate Cancer Working Party Investigators Group. Br J Urol. 1997;79:235
  19. Hussain MH, Goldman B, Tangen CM, Higano CS, Petrylak DP, Crawford ED. Use of prostate-specific antigen progression (PSA-P) to predict overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. J Clin Oncol. 2008;26(suppl):abstract 5015
  20. Makarov DV, Humphreys EB, Mangold LA, Carducci MA, Partin AW, Eisenberger MA, et al. The natural history of men treated with deferred androgen deprivation therapy in whom metastatic prostate cancer developed following radical prostatectomy. J Urol. 2008;179:156

 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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