[NCI CIRB] EA8184: A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers

Principal Investigator

Ryan Kopp

Study Purpose

This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance. Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing.

Medical Condition(s)

Male Prostate Cancer

Eligibility Criteria

Inclusion Criteria:

Step 0 - Screening:
- Patient must have biopsy-proven adenocarcinoma of the prostate
- Patient must be on active surveillance (very low, low and favorable intermediate risk as defined by the National Comprehensive Cancer Network [NCCN])
- Patient must have a serum PSA < 10 ng/mL or prostate specific antigen density (PSAD) < 0.15 ng/mL/ g obtained within 30 days of registration
- 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 and use one provided by study
- Absolute neutrophil count (ANC) >= 1,200/mm^3 (>= 1.2 k/uL)
- Platelets >= 75,000/mm^3 (>= 75 k/uL)
- Total bilirubin =< 1.2 mg/dL (or =< 3.0 mg/dL for patients with Gilbert's syndrome)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x upper limit of normal (ULN)
- Serum creatinine =< 1.5 x ULN
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Sexually active males must use an accepted and effective method of double barrier contraception (vasectomy must be combined with a physical barrier method) or abstain from sexual intercourse for the duration of their participation in the study
- Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen available for Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue for eligibility and stratification. Tumor tissue can be submitted any time during screening

Step 1 - Randomization:
- Patient must meet all Step 0 eligibility criteria at the time of their registration to Step 1
- Patient must have Gleason score (3+3) or predominant Gleason pattern 3 (3+4), =< 33% of biopsy cores, and =< 50% involvement of any biopsy core
- Patient must have a Ki-67 expression of 5% or more in tumor tissue

Exclusion Criteria:

Step 0 - Screening:
- 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 a history of renal or hepatic disease, including history of hepatitis B and C
- 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. 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

Age Range

21 - 99

Healthy Volunteers Needed


Duration of Participation

18 months (6 months of treatment and an additional 12 months from the date registration for follow-up/survival). All patients will also be followed for response until progression.

Minors Included



Knight Cancer Institute Clinical Trials,, 503-494-1080



Recruitment End


Compensation Provided


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