Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Epigallocatechin gallate

Criteria

Criteria:

• Biopsy-proven adenocarcinoma of the prostate meeting the following criteria:

organ-confined disease; treatable by prostatectomy

• PSA < 50 ng/mL

• ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%

• Bilirubin normal

• AST and ALT normal

• Creatinine normal

• Fertile patients must use effective contraception

• No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness or social situations that would limit study compliance

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extract

• No prior therapy for prostate cancer (i.e., hormone therapy, radiation therapy, or surgery)

• No systemic treatment (chemotherapy) and/or radiation therapy for any malignancy within the past 5 years (excluding nonmelanoma skin cancer or cancer confined to organs with surgical removal as the only treatment)

• No regular tea consumption (> 6 servings of hot tea or 12 servings of iced tea or equivalent combination per week) within the past month

• No other concurrent investigational agents

• No other concurrent consumption of tea or tea-derived products from green, black, or oolong tea