Phase II, Randomized, Double Blind, Placebo Controlled Pilot Study of Polyphenon E in Men With Localized Prostate Cancer Scheduled to Undergo Radical Prostatectomy
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Change in levels of intermediate biomarkers in prostate tissue (Ki-67, Bcl2, cyclin D, KiP1/P27, VEGF, and CD31) during treatment with defined green tea catechin extract or placebo during the period between biopsy and prostatectomy
Baseline and at or after 6 weeks of treatment
No
Sanjay Gupta
Principal Investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
CASE13805
NCT01340599
October 2006
April 2007
Name | Location |
---|---|
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |