Study on Green Tea Extracts for Men Under Active Surveillance for Prostate Cancer

Inclusion Criteria

• Men aged 18 or older.
• Diagnosed with low to intermediate grade prostate cancer, confirmed by a biopsy with at least 12 samples.
• Cancer must be present in at least one biopsy sample, with a Gleason score of 3+3 or mainly 3+4, affecting no more than 33% of samples and 50% of any single sample.
• Must be on or willing to start active surveillance for prostate cancer.
• Baseline PSA level must be less than 10 ng/mL.
• No previous treatments for prostate cancer, including surgery or hormone therapy.
• Good overall health with an ECOG performance status of 0 or 1.
• No history of liver or kidney disease, including hepatitis B or C.
• Meet specific blood test requirements for liver and kidney function.
• Willing to avoid supplements containing green tea catechins.
• Limit tea consumption to less than three servings per week.
• Agree to stop current vitamin/mineral supplements and use those provided by the study.
• Willing to take the study medication or placebo with meals as directed.

Exclusion Criteria

• Have had previous prostate cancer treatments like surgery, radiation, or hormone therapy.
• Currently or recently (within 3 months) using 5-alpha-reductase inhibitors like finasteride or dutasteride.
• Have prostate cancer that has spread to other parts of the body.
• Have received hormone therapy, immunotherapy, chemotherapy, or radiation for any cancer in the past 2 years.
• Currently taking any other investigational drugs.
• Have a history of allergic reactions to tea or similar compounds.