Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy(JCOG0401)

UMIN ID: C000000026

Registered date:22/07/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: prostate cancer
• Date of first enrollment: 2004/05/01
• Target sample size: 210
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

endocrine therapy
radiotherapy +/- endocrine therapy

Outcome(s)

• Primary Outcome: TTF of bicalutamide
• Secondary Outcome: TTF of protocol treatment, clinical progression free survival, overall survival, adverse events and patient-reported quality of life

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male
• Exclude criteria: 1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ; 2) mental disease or mental symptoms which would affect participant's decision to participate; 3) continuous medication of steroids (exclude external use of steroids for skin) ; 4) ischemic heart disease or arrhythmia which needs medical treatment; 5) poorly controlled hypertension; 6) poorly controlleddiabetes mellitus; 7) history of cerebral infarction or myocardial infarction within 6 months; 8) liver cirrhosis 9) interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT00138008