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Prostate Cancer and Prostatic Diseases
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Bicalutamide 80 mg combined with a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A monotherapy in advanced prostate cancer: findings from a phase III randomized, double-blind, multicenter trial in Japanese patients

Prostate Cancer and Prostatic Diseasesvolume 10, pages194–201 (2007)Cite this article

Abstract

To compare combination therapy with bicalutamide 80 mg and a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A alone in Japanese men with untreated advanced prostate cancer. A total of 205 patients with stage C/D prostate cancer were randomized to either LHRH-A+once-daily oral bicalutamide 80 mg or placebo. Primary study variables have been reported previously. Secondary variables included: time to achieve prostate-specific antigen⩽4 ng/ml, time-to-treatment failure (TTTF), time-to-disease progression (TTP), overall survival (OS), adverse events and adverse drug reactions. Following combination therapy with bicalutamide 80 mg, there were significant (P<0.001) advantages over LHRH-A alone in terms of TTTF and TTP, but the difference in the interim OS was not statistically significant. First-line combination therapy with bicalutamide 80 mg in Japanese patients with advanced prostate cancer offers significant benefits over LHRH-A alone, with respect to TTTF and TTP. Follow-up for OS continues.

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Acknowledgements

Financial sponsorship for this trial was provided by AstraZeneca.

We thank Dr Chris Rapier, PhD, from Complete Medical Group, who provided editing assistance on behalf of AstraZeneca. We also thank Dr Toshihiko Kotake for valuable medical advice and the study institutions for data collection.

Study institutions, listed in descending order of the number of patients that they enlisted*, were:

Harasanshin Hospital (22); Kansai Medical University Hospital (nine); Shimane University Hospital (eight); Nishi-Kobe Medical Center (seven); Okayama University Hospital (seven); Fujieda Municipal General Hospital (six); Kurashiki Central Hospital (six); Nihon University Itabashi Hospital (six); Shikoku Cancer Center (six); Showa University Hospital (six); Tokushima University Hospital (six); Gifu University Hospital (five); Kanazawa University Hospital (five); Kobe University Hospital (five); Kyushu University Hospital (five); Nagasaki Medical Center (five); Nara University of Medical Science Hospital (five); Tokyo Medical University Hospital (five); Hirosaki University School of Medicine and Hospital (four); Hiroshima University Hospital (four); Kawasaki Medical School Hospital (four); Keio University Hospital (four); Kyoto University Hospital (four); Nagasaki University Hospital (four); Osaka University Hospital (four); Sasebo Municipal General Hospital (four); Tokyo Women's Medical University Hospital (four); Kitasato University Hospital (three); Osaka City University Hospital (three); The University of Tokyo Hospital (three); Teikyo University Ichihara Hospital (three); University Hospital, Kyoto Prefectural University of Medicine (three); Yamagata University Hospital (three); Asahi Central Hospital (two); Jikei University School of Medicine Hospital (two); Kochi Medical School Hospital (two); Nagoya City University Hospital (two); Nagoya Daini Red Cross Hospital (two); Niigata Cancer Center Hospital (two); Niigata University Medical and Dental Hospital (two); Sapporo Medical University Hospital (two); Tohoku University Hospital (two); Tsukuba University Hospital (two); Yokohama City University Hospital (two); Chiba University Hospital (one); Hokkaido University Hospital (one); Osaka Medical Center for Cancer and Cardiovascular Diseases (one); Toranomon Hospital (one); Tottori University Hospital (one).

*Values in parentheses represent the number of enrolled patients.

Author information

Authors and Affiliations

  1. Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    M Usami

  2. Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan

    H Akaza

  3. Department of Urology, Tohoku University School of Medicine, Miyagi, Japan

    Y Arai

  4. Department of Urology, Fujieda Municipal General Hospital, Shizuoka, Japan

    Y Hirano

  5. Department of Urology, Tokushima University Hospital, Tokushima, Japan

    S Kagawa

  6. Department of Urology, Nagasaki University School of Medicine, Nagasaki, Japan

    H Kanetake

  7. Department of Urology, Kyushu University Hospital, Fukuoka, Japan

    S Naito

  8. Shikoku Cancer Center, Ehime, Japan

    Y Sumiyoshi

  9. Department of Urology, Nihon University Itabashi Hospital, Tokyo, Japan

    Y Takimoto

  10. Department of Urology, Kurashiki Central Hospital, Okayama, Japan

    A Terai

  11. Showa University Hospital, Tokyo, Japan

    H Yoshida

  12. Department of Biostatistics, School of Health Sciences and Nursing, The University of Tokyo, Tokyo, Japan

    Y Ohashi

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  1. M Usami

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Correspondence toM Usami.

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Usami, M., Akaza, H., Arai, Y.et al. Bicalutamide 80 mg combined with a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A monotherapy in advanced prostate cancer: findings from a phase III randomized, double-blind, multicenter trial in Japanese patients.Prostate Cancer Prostatic Dis10, 194–201 (2007). https://doi.org/10.1038/sj.pcan.4500934

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