Status:
COMPLETED
Green Tea Extract and Prostate Cancer
Lead Sponsor:
Louisiana State University Health Sciences Center Shreveport
Collaborating Sponsors:
Polyphenon Pharma
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
Detailed Description
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between prostate biopsy and radical prostatectomy in men with recently diagnosed prostate cancer. En...
Eligibility Criteria
Inclusion
- recent biopsy positive for prostate cancer
- scheduled for prostatectomy
- must be able to swallow capsules
- Palpable mass by digital rectal examination (DRE)
- Ability to give informed consent and willingness to adhere to study protocol
- Age ≥ 18 years and less than 75
Exclusion
- abnormal liver function
- Prior hormonal or surgical therapy for prostate cancer
- Liver or kidney problems that would interfere with metabolism of study drug
- Any condition that would hamper informed consent or ability to comply with study protocol
- Participation in another research study in the last three months
- Known malignancy at any site other than prostate
- Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00676780
Start Date
May 1 2004
End Date
December 1 2008
Last Update
August 8 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103