To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring

Inclusion Criteria

• ELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING)
• Patient must be >= 21 years of age
• Patient must speak English or Spanish
• Patient must have biopsy-proven (consisting of >= 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core in the most recent biopsy using a TRUS biopsy or TP or an mpMRI-guided biopsy of the prostate
• Patient must be on active surveillance (local - Gleason 3+3/Grade Group 1 [GG1] or Gleason 3+4/GG2) where < 6 of 12 cores are positive for cancer * NOTE: In cases where the total number of biopsies are < 12 cores (6 or 8 cores), < 3/6 cores or < 4/8 cores must be positive for cancer to meet eligibility criteria
• Patient’s baseline biopsy must have occurred at least 6 months but not more than 18 months prior to preregistration to step 0. * NOTE: Patient is to be scheduled for a follow-up prostate biopsy 6 months after the initiation of treatment on this study
• Patient must have a serum PSA < 10 ng/mL obtained within 30 days of preregistration
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0−1
• Patient must be willing to abstain from consumption of any supplements containing green tea catechins
• Patient must be willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week (serving size of 8 oz)
• Patient must be willing to discontinue current vitamin/mineral supplement use if it contains green tea products and use one provided by study
• Patient must be willing to take study agent or placebo at the dose specified with meals
• Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
• Patient must not have had prior treatment for prostate cancer, including focal therapy, with surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen deprivation therapy
• Patient must not have prostate cancer with distant metastases
• Patient must not have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years prior to step 0 pre-registration. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Patient must not receive any other investigational agents while on this study
• Patient must not have a history of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to green tea extracts
• Patient should not be on Finasteride or Dutasteride during study * NOTE: If patient is willing to discontinue these drugs and upon approval by patient’s Doctor of Medicine (MD), patient can proceed to be screened for this clinical trial
• Patient must not have a history of other cancers except for nonmelanoma skin cancer
• Absolute neutrophil count >= 1,200/mm^3 (>= 1.2 k/uL) (obtained within 30 days prior to step 0 pre-registration)
• Platelets >= 75,000/mm^3 (>= 75 k/uL) (obtained within 30 days prior to step 0 pre-registration)
• Total bilirubin =< 1.2 mg/dL (or =< 3.0 mg/dL for patients with Gilbert’s syndrome) (obtained within 30 days prior to step 0 pre-registration)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x upper limit of normal (ULN) (obtained within 30 days prior to step 0 pre-registration)
• Serum creatinine =< 1.5 x ULN (obtained within 30 days prior to step 0 pre-registration)
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
• Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen available for Gleason score confirmation (Gleason 3+3/GG1 or Gleason 3+4/GG2) and % Ki-67 expression (3% or more) in tumor tissue for eligibility and stratification. Tumor tissue can be submitted any time during screening * Tumor tissue specimen has been collected and is ready to ship to H. Lee Moffitt Cancer Center & Research Institute ** H. Lee Moffitt Cancer Center & Research Institute will perform Gleason score confirmation and % Ki-67 expression in tumor tissue and notify the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Operations Office within 3-4 business days of receipt of the tumor tissue specimen
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1)
• Patient must meet all step 0 pre-registration eligibility criteria at the time of their step 1 randomization
• Patient must be on active surveillance (Gleason 3+3/GG1 or Gleason 3+4/GG2) where < 6 of 12 cores are positive for cancer, confirmed via central review, as defined by the National Comprehensive Cancer Network [NCCN]) * NOTE: In cases where the total number of biopsies are < 12 cores (6 or 8 cores), < 3/6 cores or < 4/8 cores must be positive for cancer to meet eligibility criteria and must be confirmed via central review
• Patient must have % Ki-67 expression of 3% or more in at least 1 core positive for tumor confirmed via central review
• Patient must not have a history of renal or hepatic disease, including history of hepatitis B (hepatitis B virus [HBV] core antibody) and C (hepatitis C virus [HCV] core antibody)