Status:
COMPLETED
Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the bioavailability of defined green tea catechin extract in prostate tissue after treatment with defined green tea extract in patients with prostate cancer. SECONDA...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00459407
Start Date
March 1 2007
End Date
August 1 2010
Last Update
October 8 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Cancer Center - Tucson
Tucson, Arizona, United States, 85724-5024