NCT01340599

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

Phase II, Randomized, Double Blind, Placebo Controlled Pilot Study of Polyphenon E in Men With Localized Prostate Cancer Scheduled to Undergo Radical Prostatectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: I. To evaluate the short-term effects of daily Polyphenon E (defined green tea catechin extract) administration (800 mg epigallocatechin-3-gallate \[EGCG\] once daily \[QD\]) during the interval between prostate biopsy and radical prostatectomy (approximately 6 weeks) in men with localized prostate cancer. II. Compare the change in levels of intermediate biomarkers (Ki-67, B-cell lymphoma 2 \[Bcl2\], cyclin D, KiP1/P27, vascular endothelial growth factor \[VEGF\], and cluster of differentiation \[CD\]31) in biopsy (pre-treatment) and prostatectomy (post-treatment) specimens collected from subjects treated with Polyphenon E or placebo during the period between biopsy and prostatectomy. III. Compare the change in pre- and post-treatment serum prostate-specific antigen (PSA) level in subjects treated with Polyphenon E or placebo during the period between biopsy and prostatectomy. IV. Evaluate bioavailability of catechins from Polyphenon E (plasma and tissue catechin levels, catechin metabolites in urine). V. Evaluate the safety and tolerability of Polyphenon E in this subject population. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive defined green tea catechin extract orally (PO) QD for 4-10 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo radical prostatectomy between days 28-70. ARM II: Patients receive placebo PO QD for 4-10 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo radical prostatectomy between days 28-70. After completion of study treatment, patients are followed up periodically.

Conditions

• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	defined green tea catechin extract	Given PO
OTHER	placebo	Given PO
OTHER	immunohistochemistry staining method	Correlative studies
OTHER	immunoenzyme technique	Correlative studies
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	therapeutic conventional surgery	Undergo radical prostatectomy
OTHER	high performance liquid chromatography	Correlative studies
OTHER	mass spectrometry	Correlative studies

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2011-04-22
• Last updated: 2012-03-15

Locations

1 site across 1 country: United States