Defined Green Tea Catechin Extract in Treating Patients With Localized Prostate Cancer Undergoing Surgery

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

In brief

This randomized pilot phase II trial studies the side effects and how well defined green tea catechin extract works in treating patients with localized prostate cancer undergoing surgery. Defined green tea catechin extract contains ingredients that may prevent or slow the growth of certain cancers.

Key facts

Study ID

NCT01340599

Run by

Case Comprehensive Cancer Center

People needed

5

Starts

2006-10-01

Expected to finish

2007-04-01

Last updated by the study team

2012-03-15

Who can join

Age: 45 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Prostate biopsy positive for cancer; clinically localized T1 and T2 stage disease expected, with biopsy specimen available for baseline biomarker measurements
• Scheduled for a radical prostatectomy
• Willing to sign an Institutional Review Board (IRB)-approved informed consent document and adhere to the protocol
• Willing and able to take oral medications
• Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea constituents for the duration of the study

You may not qualify if…

• Prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy
• Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization
• Signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
• Serum creatinine >= 1.5 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) >= ULN
• Aspartate aminotransferase (AST) >= ULN
• Alkaline phosphatase (ALP) >= ULN
• Albumin (ALB) =< lower limit of normal (LLN)
• Total bilirubin >= ULN
• Known malignancy at any site within the last five years; with the exception of basal cell carcinoma (BCC)
• Participation in a research trial within the past three months
• Any condition that would interfere with the ability to give informed consent or comply with the study protocol
• Hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules
• Concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week

Where it is running

• Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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