A multi-center trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in stage C,D prostate cancer patients

UMIN ID: C000000240

Registered date:20/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 2000/07/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Taking GTE tablet with hormonal therapy
hormonal therapy alone

Outcome(s)

• Primary Outcome: Time to hormone refractory
• Secondary Outcome: Survival time (disease specific survival, overall survival) and adverse event

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: a) Patients who have active double cancer. b) Patients who have digestive tract ulcer and a critical liver, kidney, and heart disease. c) Patients who experienced palpitation and heartburn with coffee or tea. d) Patients who have abnormality in a blood cells or biochemical examination of blood classified into two or more grade of NCI toxicity criteria e) Patients considered not to have a six months prognosis. f) Patients who are judged to be unsuitable for the study.

Related Information

• Primary Sponsor: The University of Tsukuba Graduate Schools
• Secondary Sponsor: Tsukuba prostate cancer prevention study group
• Source(s) of Monetary Support: None