Table 2.

Changes in intermediate endpoint biomarkers of PCa observed in Phase II clinical trials using GTCs.

Target Population (Ref)	Number of Subjects	Dose of GTC (EGCG)	Duration of Intervention	Biomarkers Observed
HGPIN (Betuzzi et al. [67,68])	60	200 mg TID	12 months	Reduction in progression to PCa in treatment arm Improvement in prostate symptom score
HGPIN (Kumar et al. [75])	97	200 mg BID Poly E®	12 months	Cumulative rate of PCa plus ASAP among men with HGPIN without ASAP at baseline, revealed a decrease in this composite endpoint: (p < 0.024). Decrease in ASAP diagnoses on the Poly E® (0/26) compared with the placebo arm (5/25). Decrease in serum PSA was observed in the Poly E arm [−0.87 ng/mL; 95% CI, −1.66 to −0.09].
PCa patients (Henning et al. [88])	113	6 cups of green tea, black tea or water	3–8 weeks	Nuclear staining of NF-κB was significantly decreased in RP tissue of men consuming green tea (p = 0.013) but not black tea (p = 0.931) compared to water control. Tea polyphenols were detected in prostate tissue from 32 of 34 men consuming green tea but not in the other groups. Evidence of a systemic antioxidant effect was observed (reduced urinary 8OHdG) only with GTC consumption (p = 0.03). Significant decrease in serum PSA levels (p < 0.05).
PCa patients (McLarty et al. [89])	26	800 mg of EGCG Poly E®	3–6 weeks	Significant reduction in serum levels of PSA, HGF, and VEGF in men with PCa after brief treatment with EGCG (Poly E®), with no elevation of liver enzymes.
PCa patients-pre-prostatectomy (Nguyen et al. [84])	52	800 mg of EGCG Poly E®	3–6 weeks	Proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on Poly E® but was not statistically significant. Favorable but not statistically significant changes in serum PSA, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes.

Abbreviations: 8OHdG, 8-hydroxydeoxy-guanosine; ASAP, atypical small acinar proliferation; BID, twice a day; CI, confidence interval; GTC, green tea catechins; HGF, hepatocyte growth factor; HGPIN, high-grade prostatic intraepithelial neoplasia; EGCG, epigallocatechin-3-gallate; PCa, prostate cancer; Poly E, polyphenon E; PSA, prostate specific antigen; RP, radical prostatectomy; TID, three times a day; VEGF, vascular endothelial growth factor.