Phase II, Randomized, Double Blind, Placebo Controlled Pilot Study of Polyphenon E in Men With Localized Prostate Cancer Scheduled to Undergo Radical Prostatectomy
45 Years
75 Years
Male
Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
Trial Information
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
Baseline and at or after 6 weeks of treatment
Safety Issue:
No
Principal Investigator
Sanjay Gupta
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE13805
NCT ID:
NCT01340599
Start Date:
October 2006
Completion Date:
April 2007
Related Keywords:
- Stage I Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIB Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
