Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Green tea contains ingredients that may prevent or slow the growth of certain
      cancers. It is not yet known whether green tea is more effective than black tea or water in
      treating prostate cancer.

      PURPOSE: This randomized phase II trial is studying green tea to see how well it works
      compared with black tea and water in treating patients with prostate cancer undergoing
      surgery.
    

Detailed description: 
      OBJECTIVES:

        -  to determine the effect of GT and BT consumption on apoptosis (TUNEL, ratio Bax:Bcl-2),
           proliferation, oxidation, and inflammation in malignant radical prostatectomy tissue
           compared to water control using immunohistochemistry.

        -  to examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh
           frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and
           serum prostate-specific antigen (PSA) levels.

      OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 3 treatment
      arms.

        -  Arm I: Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of
           unacceptable toxicity.

        -  Arm II: Patients receive 6 cups of water daily for 2-8 weeks in the absence of
           unacceptable toxicity.

        -  Arm III: Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the
           absence of unacceptable toxicity.

      Patients undergo radical prostatectomy.

      Blood and urine samples, as well as tissue from diagnostic biopsy and radical prostatectomy
      specimens, are obtained for laboratory correlative studies. Samples are assessed by IHC,
      high-performance liquid chromatography, or mass spectrometry for changes in prostate tumor
      grade, stage, and margin status; concentrations of total and free tea polyphenols (i.e.,
      EGCG, EC, EGC, ECG), theaflavins, and conjugated/colonic tea metabolites; biomarkers of
      prostate cancer development and progression (i.e., serum PSA, proliferation [i.e., Ki-67],
      apoptosis [i.e., TUNEL, Bax/Bcl-2 ratio], inflammation [i.e., NFkB]), and oxidative status
      (i.e., 8OhdG/dG ratio); and genotype and gene expression of metabolizing enzymes (i.e., COMT,
      UGT, and SULT). Serum samples are also assessed by ex vivo LNCaP cell culture assay for
      antiproliferative activity and by competitive chemiluminescent immunoassay for concentrations
      of PSA, IGF-1, IGFBP-3, testosterone, SHBG, and DHEA-sulfate.
    

Intervention name(s): green tea; placebo; decaffeinated black tea
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 6 cups of green tea daily for 2-8 weeks; 6 cups of water daily for 2-8 weeks; 6 cups of decaffeinated black tea daily for 2-8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer