Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy (JCOG0401)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
time to treatment failure (TTF) of bicalutamide
time to treatment failure (TTF) of bicalutamide
No
Seiji Naito, MD, Ph.D.
Study Chair
Graduate School of Medical Science, Kyushu University
Japan: Ministry of Health, Labor and Welfare
JCOG0401
NCT00138008
May 2004
May 2016
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