Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green
      tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical
      prostatectomy. Side effects of green tea extract and quercetin in combination with green tea
      extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer
      and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies
      quercetin was found to enhance the anticancer effects of green tea. This trial is designed to
      translate these findings forward in a short-term human intervention trial.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To investigate the prostate tissue concentration of epigallocatechin gallate (EGCG),
      epicatechin gallate (ECG) and quercetin and their methylated metabolites in men scheduled for
      prostatectomy and consuming green tea (GT)extract (N=15) or GTextract with quercetin (N=15)
      for 3 weeks prior to prostatectomy.

      II. To determine the concentration of EGCG, ECG, epigallocatechin (EGC), epicatechin (EC) and
      quercetin and the methylated metabolites in plasma collected before (T=0) and two hours (T=2)
      after the intake of the morning dose of GTextract and placebo or GTextract with quercetin
      during the third week of intervention.

      III. To determine the effect of GTextract/quercetin intervention on reducing the enzyme
      activity and protein and gene expression of catechol-O-methyltransferase (COMT) and
      deoxyribonucleic (DNA) (cytosine-5) methyltransferase 1 (DNMT1) as well as protein and gene
      expression of multidrug resistance transport protein 1 (MRP1) in prostate tissue collected in
      specific aim 1 and COMT activity in erythrocytes from blood collected at baseline and week 3.

      IV. To determine the inter-individual variation in genotype of COMT in buffy coat DNA.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive GT extract orally (PO) twice daily (BID) and quercetin PO BID for 3-6
      weeks before undergoing prostatectomy.

      ARM II: Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing
      prostatectomy.
    

Intervention name(s): green tea extract; quercetin; placebo; therapeutic conventional surgery; laboratory biomarker analysis
Intervention type(s): Dietary Supplement; Drug; Other; Procedure; Other
Intervention description(s): Given PO; Given PO; Given PO; Undergo prostatectomy; Correlative studies
Other intervention name(s): green tea polyphenols; C.I. natural yellow 10; PLCB
Intervention MeSH terms: Quercetin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention