Green Tea Extract in Treating Patients With Low-Risk Prostate Cancer

Inclusion Criteria:

Patients must be males with histologically confirmed and clinically localized low-grade and low-volume prostate cancer demonstrated at the time of initial diagnosis
Prostate biopsy must be positive for cancer: clinically localized T1c or T2a, PSA ≤ 10, Gleason ≤ 6 at the time of initial diagnosis. As the intent of serial biopsy is to ensure that the disease has not progressed to the stage or grade of requiring treatment, the presence of a negative biopsy following an initial positive biopsy (coupled with clinically localized T1c or T2a PSA ≤10 and Gleason ≤6 for a patient who has had no treatment, will not render the patient ineligible. If the consecutive biopsy is either negative, or if positive and remains clinically localized T1c or T2a, PSA≤10 and Gleason ≤6, the patient is eligible
Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Advodart, and anti-inflammatory agents
Willing to sign an Institutional Review Board (IRB)-approved informed consent document and adhere to the protocol
Willing and able to take oral medications
Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea for the duration of the study
Subjects must have newly diagnosed (within 1 year), previously untreated prostate cancer without other malignancy; therefore, no prior therapies are permitted
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ institutional upper limit of normal
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ institutional upper limit of normal
Serum creatinine within normal institutional limits

Subject must be willing to limit alcohol to moderate use which is defined as: up to one drink a day for women or two drinks a day for men; examples of one drink include:

Beer: 12 fluid ounces (355 milliliters)
Wine: 5 fluid ounces (148 milliliters)
Distilled spirits (80 proof): 1.5 fluid ounces (44 milliliters)

Exclusion Criteria:

Patients who are receiving any other investigational agents
Patients with known concurrent malignancy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Sunphenon 90 DCF-T or other agents used in this study
Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization; or concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients who have received prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy
Signs or symptoms of progressive or uncontrolled liver disease
Known malignancy at any site within the last two years; with the exception of basal cell carcinoma (BCC)
Participation in a research trial within the past three months
Any condition that would interfere with the ability to give informed consent or comply with the study protocol
Hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules
Patients with a known history of Gilbert's syndrome