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Japanese Journal of Clinical Oncology 2005 35(1):34-36; doi:10.1093/jjco/hyi007
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© 2005 Foundation for Promotion of Cancer Research

Clinical Trial Note

Randomized Controlled Trial to Evaluate Radiotherapy ± Endocrine Therapy Versus Endocrine Therapy Alone for PSA Failure after Radical Prostatectomy: Japan Clinical Oncology Group Study JCOG 0401

Akira Yokomizo1, Hiroshi Kawamoto2, Keiji Nihei3, Naoki Ishizuka2, Yoshiyuki Kakehi4, Ken-ichi Tobisu5 and Seiji Naito1

1 Department of Urology, Graduate School of Medical Science, Kyushu University, Fukuoka, 2 Cancer Information and Epidemiology Division, National Cancer Center Research Institute, Tokyo, 3 Radiation Oncology Division, National Cancer Center Hospital East, Kashiwa, Chiba, 4 Department of Urology, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa and 5 Shizuoka Cancer Center Hospital, Sunto-gun, Shizuoka, Japan

For reprints and all correspondence: Seiji Naito, Department of Urology, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan. E-mail: naito{at}uro.med.kyushu-u.ac.jp

Received July 9, 2004; accepted November 3, 2004

A randomized controlled trial has started in Japan to evaluate radiotherapy and endocrine therapy for prostate-specific antigen (PSA) failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy for localized prostate cancer (T1–2N0M0) are randomized into treatment groups of either radiotherapy ± endocrine therapy or endocrine therapy alone. The Urologic Oncology Study Group (UOSG) in the Japan Clinical Oncology Group (JCOG) composed of 36 specialized institutions will recruit 200 patients. The primary end-point is time to treatment failure (TTF) of bicalutamide, and secondary end-points are TTF of protocol treatment, progression-free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the JCOG approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.

Key Words: prostate cancer • prostatectomy • PSA failure • endocrine therapy • radiation


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S. Naito
Evaluation and Management of Prostate-specific Antigen Recurrence After Radical Prostatectomy for Localized Prostate Cancer
Jpn. J. Clin. Oncol., July 1, 2005; 35(7): 365 - 374.
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