Clinical Trial of Green Tea Catechins in Men on Active Surveillance

Inclusion Criteria:

• 18 years of age or older

• Biopsy-proven (consisting of ≥ 12 tissue cores) adenocarcinoma of the prostate withcancer present in at least one biopsy core (TRUS or/and mpMRI/TRUS fusion), Gleasonscore (3+3) or predominant Gleason pattern 3 (3+4), ≤ 33% of biopsy cores, and ≤50%involvement of any biopsy core (Participant meets all criteria for ActiveSurveillance as determined by MD)

• Willing to start or continue on active surveillance

• Baseline/screening serum PSA <10 ng/mL

• No other prior treatment for PCa, including focal therapy

• ECOG performance status 0-1

• No history of renal or hepatic disease, including history of hepatitis B and C

• Meet hematological eligibility parameters (Neutrophil count ≥ 1,200/mm3 (≥1.2 k/μL),Stable platelet count ≥ 75,000/mm3 (≥ 75k/μL) Hepatic and renal function eligibilityparameters, serum total Bilirubin ≤ULN (ULN: 1.2 mg/dl) (or ≤3.0 mg/dL for patientswith Gilbert's syndrome), AST or ALT <1.5x ULN and Serum creatinine ≤1.5 x ULN

• Willing to abstain from consumption of any supplements containing GTC

• Willing to restrict tea consumption to less than three (3) servings of hot tea orthree (3) servings of iced tea per week

• Willing to discontinue current vitamin/mineral supplement use and use one providedby study

• Willing to take study agent or placebo at the dose specified with meals.

Exclusion Criteria:

• Have had prior treatment for PCa by surgery, irradiation, local ablative (i.e.,cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy)

• Men who are currently treated or those treated in the past 3 months prior to day ofrandomization with 5- alpha-reductase inhibitors (e.g., finasteride, dutasteride)

• Participants who have PCa with distant metastases

• Participants who have been treated with: hormone therapy, immunotherapy,chemotherapy and/or radiation, for any malignancies within the past 2 years prior toregistration.Patients with a prior or concurrent malignancy whose natural history ortreatment does not have the potential to interfere with the safety or efficacyassessment of the investigational regimen are eligible for this trial. All patientswith metastatic disease will be excluded

• Participants may not be receiving any other investigational agents

• History of allergic reactions attributed to tea or compounds of similar chemical orbiologic composition to green tea extracts.