Combined androgen blockade with bicalutamide for advanced prostate cancer§

Long-Term Follow-Up of a Phase 3, Double-Blind, Randomized Study for Survival


  • We thank the patients and their families for their participation in this study. We also thank the physicians and support staff in each institute and Dr. Sharon Gladwin from Complete Medical Communications, who provided medical writing support.

  • Institutions participating in the study: Hokkaido University Hospital, Sapporo Medical University Hospital, Hirosaki University School of Medicine and Hospital, Tohoku University Hospital, Yamagata University Hospital, Tsukuba University Hospital, Teikyo University Chiba Medical Center, Asahi Hospital, Nihon University Itabashi Hospital, Toranomon Hospital, Keio University Hospital, Showa University Hospital, the University of Tokyo Hospital, the Jikei University School of Medicine, Tokyo Medical University Hospital, Tokyo Women's Medical University Hospital, Yokohama City University Hospital, Kitasato University Hospital, Fujieda Municipal General Hospital, Niigata University Medical and Dental Hospital, Niigata Cancer Center Hospital, Kanazawa University Hospital, Nagoya Daini Red Cross Hospital, Nagoya City University Hospital, Gifu University Hospital, University Hospital Kyoto Prefectural University of Medicine, Kyoto University Hospital, Nara Medical University Hospital, Osaka University Hospital, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka City University Hospital, Kansai Medical University Takii Hospital, Kobe University Hospital, Nishi-Kobe Medical Center, Okayama University Hospital, Kawasaki Medical School Hospital, Kurashiki Central Hospital, Hiroshima University Hospital, Shimane University Hospital, Tokushima University Hospital, Shikoku Cancer Center, Kochi Medical School Hospital, Kyushu University Hospital, Harasanshin Hospital, Nagasaki University Hospital of Medicine and Dentistry, Sasebo General Hospital, and Nagasaki Medical Center.

  • §

    See also on pages 3376-8.



A previously reported, double-blind, randomized, multicenter phase 3 trial in 205 patients with stage C/D prostate cancer compared combined androgen blockade (CAB) with luteinizing hormone-releasing hormone agonist (LHRH-A) plus bicalutamide 80 mg versus LHRH-A plus bicalutamide-matching placebo (LHRH-A monotherapy). The analysis at a median follow-up of 2.4 years indicated that CAB significantly (P < .001) prolonged the time to progression and the time to treatment failure. In the current report, survival data from a long-term follow-up (median, 5.2 years) were analyzed.


All deaths irrespective of cause and all prostate cancer-specific deaths were recorded. The data were analyzed using Cox regression analysis and the log-rank test.


At a median follow-up of 5.2 years, a significant overall survival advantage was observed in favor of CAB over LHRH-A monotherapy (Cox regression analysis: hazard ratio, 0.78; 95% confidence interval, 0.60-0.99; P = .0498; log-rank test: P = .0425). The difference in cause-specific survival between the 2 groups was not significant. The achievement of a prostate-specific antigen (PSA) nadir concentration ≤1 ng/mL was a prognostic factor for improved survival. More patients attained PSA nadir concentrations ≤1 ng/mL with CAB compared with patients who received LHRH-A monotherapy (81.4% vs 33.7%; P < .001).


CAB with bicalutamide 80 mg offered a significant overall survival benefit compared with LHRH-A monotherapy without reducing tolerability in patients with locally advanced or metastatic prostate cancer. Cancer 2009. © 2009 American Cancer Society.