The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy.
A randomized controlled trial is conducted in Japan to evaluate radiotherapy followed by endocrine therapy for PSA failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy under a diagnosis of localized prostate cancer (T1-2 N0M0) are randomized into treatment group of either radiotherapy followed by endocrine therapy or endocrine therapy alone. Urologic Oncology Study Group (UOSG) in the JCOG composed of 36 specialized institutions will recruit 200 patients. The primary endpoint is time to treatment failure (TTF) of bicalutamide and secondary endpoints are TTF of protocol treatment, progression free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the Japan Clinical Oncology Group (JCOG) approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Drug: endocrine therapy
Procedure/Surgery: radiotherapy
time to treatment failure (TTF) of bicalutamide
Time frame: time to treatment failure (TTF) of bicalutamide
TTF of protocol treatment
Time frame: TTF of protocol treatment
clinical progression free survival
Time frame: time to clinical progression
overall survival
Time frame: overall
adverse events
Time frame: overall
patient-reported quality of life
Time frame: 1 year
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Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, Japan
Akita University School of Medicine
Akita,Hondo,1-1-1, Akita, Japan
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan
Graduate School of Medical Science, Kyushu University
Fukuoka, Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, Japan
Gunma University
Maebashi,Showa,3-39-15, Gunma, Japan
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan
Sapporo Medical University
S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan
...and 24 more locations