Green Tea Extract in Treating Patients With Low-Risk Prostate Cancer
Condition: Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: active surveillance; Sunphenon; laboratory biomarker analysis; Questionnaire Administration
Intervention description: Undergo active surveillance; Given PO; Correlative studies; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well green tea extract works in treating patients
      with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or
      slow the growth of certain cancers.
    

Eligibility criteria:

        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