Japanese Journal of Clinical Oncology Advance Access originally published online on November 2, 2006
Japanese Journal of Clinical Oncology 2006 36(12):789-793; doi:10.1093/jjco/hyl115
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© 2006 Foundation for Promotion of Cancer Research
A Randomized Trial Comparing Radical Prostatectomy Plus Endocrine Therapy versus External Beam Radiotherapy Plus Endocrine Therapy for Locally Advanced Prostate Cancer: Results at Median Follow-up of 102 Months

1 Department of Urology, School of Medicine, Chiba University, Chiba
2 Urology Division, National Cancer Center Hospital, Tokyo
3 Department of Urology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka
4 Department of Urology, Nihon University School of Medicine, Tokyo
5 Department of Urology, Faculty of Medicine, Kyoto University, Kyoto
6 Shikoku Cancer Center, Matsuyama, Japan
For reprints and all correspondence: Koichiro Akakura, Department of Urology, Tokyo Kosei Nenkin Hospital, 5-1 Tsukudo-cho, Shinjuku-ku, Tokyo 162-8543, Japan. E-mail: akakurak{at}tkn-hosp.gr.jp
Received May 6, 2006; accepted August 14, 2006
BACKGROUND: To investigate the optimal treatment of locally advanced prostate cancer, a prospective randomized trial was conducted to compare radical prostatectomy plus endocrine therapy versus external beam radiotherapy plus endocrine therapy.
METHODS: One hundred patients with T2b-3N0M0 prostate cancer were enrolled and 95 were evaluated. Of 95 cases, 46 underwent radical prostatectomy with pelvic lymph node dissection and 49 were treated with external beam radiation by linear accelerator with 4050 Gy to the whole pelvis and 20-Gy boost to the prostatic area. For all patients, endocrine therapy was initiated 8 weeks before surgery or radiotherapy and continued thereafter. The long-term outcome and morbidity were examined.
RESULTS: Median follow-up period was 102 months. At 10 years overall survival rates in the surgery group were better than the radiation group (76.2% versus 71.1% for biochemical progression-free rates; P=0.25, 83.5% versus 66.1% for clinical progression-free rates; P=0.14, 85.7% versus 77.1% for cause-specific survival rates; P=0.06, and 67.9% versus 60.9% for overall survival rates; P=0.30), although none of them reached statistical significance. Erectile dysfunction was recognized in almost all patients as a result of continuous endocrine therapy. Incontinence requiring more than one pad per day was observed more frequently in the surgery group than the radiation group (P<0.01).
CONCLUSIONS: For the treatment of patients with locally advanced prostate cancer, when combined with endocrine therapy, either radical prostatectomy or external beam radiotherapy demonstrated favorable long-term outcomes. The radiation dose of 6070 Gy might not be enough for the local treatment of locally advanced prostate cancer.
Key Words: prostate cancer locally advanced randomized trial radical prostatectomy external beam radiotherapy
* The principal investigators.
Other members are listed in the Appendix at end of paper.