Bettuzzi 2006

Methods	2‐arm, double blind, placebo controlled, parallel, RT in Italy
Participants	60 men with high‐grade prostate intraepithelial neoplasia (30 in each arm)
Interventions	Three green tea catechins capsules, 200 mg each (total 600 mg/d)
Outcomes	Prostate cancer incidence, total serum PSA, changes in LUTS as assessed by IPSS and QoL scores, medical events and side‐effects
Cancer type & time of follow‐up	Prostate cancer, treatment for 1 year
Sponsor	Grant support in part by PRIN 2004 (Miur, Italy), Dr. Rizzi supported by Genprofiler Srl (Bolzano, Italy)
Notes	At end of study n = 1 tumor was detected in treatment group (incidence ˜ 3%) and n = 9 in control group (incidence ˜ 30%) ‐> suggests a 90% chemoprevention efficacy of GTCs in men subjected to high risk for developing prostate cancer (highly significant P < .01). GTCs treatment did not significantly affect PSA values throughout the study but mean value of total PSA was always lower in treatment group and a trend toward a more stable total PSA value was evident in this group. Small but significant decrease in IPSS score in GTC group for 3 months (P <0.05). Non‐significant decrease in QoL scores in 35% of men in GTC group (P = 0.08). No adverse effects were reported.