RATIONALE: Green tea extract contains substances that may slow the growth of certain cancers and may prevent the development of new cancers. PURPOSE: Phase II trial to determine the effectiveness of green tea extract in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
OBJECTIVES: I. Determine the effectiveness and toxicity of green tea extract in patients with androgen-independent metastatic prostate cancer. II. Determine the response rate and response duration in patients treated with this regimen. III. Determine whether a decline in prostate-specific antigen (PSA) coincides with evidence of disease regression in these patients. OUTLINE: Patients receive oral green tea extract six times daily for 4 months. Patients with a 50% decline in PSA, complete or partial response, or stable disease after 4 months continue treatment in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 4 months receive no further treatment. Patients are followed every 3 months for 5 years or until disease progression. If disease progression, patients are followed every 6 months for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Response rate and duration
Time frame: Up to 5 years
Disease-regression
Time frame: Up to 5 years
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