A prospective clinical trial of green tea for hormone refractory prostate cancer: an evaluation of the complementary/alternative therapy approach.

Purpose: To evaluate the efficacy and toxicity of green tea, prescribed as an alternative complementary (CAM) formulation on hormone refractory prostate cancer (HRPC).
Methods: Patients with HRCP were prescribed green tea extract capsules at a dose level of 250 mg twice daily. Efficacy and toxicity were evaluated during monthly visits. The primary endpoint was prostate-specific antigen (PSA) or measurable disease progression after a minimum of 2 months of therapy.
Results: Nineteen patients were enrolled into the study. The treatment was generally well tolerated. Twelve patients reported at least one side effect; only two of these were of moderate or severe grade. Primary toxicity was related to gastrointestinal irritation or caffeine intake. Four patients did not complete the minimum 2 months of therapy because of: intolerance (two patients), physician stoppage (one patient), death from cerebrovascular accident (one patient). Fifteen patients completed at least 2 months of therapy. Nine of these patients had progressive disease within 2 months of starting therapy. Six patients developed progressive disease after additional 1 to 4 months of therapy.
Conclusion: Green tea, as CAM therapy, was found to have minimal clinical activity against hormone refractory prostate cancer.