Back to resultsDefined Green Tea Catechin Extract in Treating Patients With Localized Prostate Cancer Undergoing Surgery
Primary Purpose
Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
defined green tea catechin extract
placebo
immunohistochemistry staining method
immunoenzyme technique
questionnaire administration
therapeutic conventional surgery
high performance liquid chromatography
mass spectrometry
Sponsored by
About this trial
This is an interventional treatment trial for Stage I Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm I (Polyphenon E)
Arm II (placebo)
Arm Description
Patients receive defined green tea catechin extract PO once daily QD for 4-10 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo radical prostatectomy between days 28-70.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in the levels of free (f) PSA
PSA exists in the serum in different molecular forms and that the proportion of "complexed" PSA (PSA-ACT) to "free" PSA(F-PSA) is higher in prostate cancer patients [16]. F-PSA-to-PSA ratio remains constant in men without prostate cancer while total PSA increases. This F-PSA to-PSA ratio is useful diagnostic tool with borderline total PSA values (4.0 to 10.0 ng/mL); additionally values of 20% to 25% F-PSA eliminates 1/3 of biopsies in some studies; and F-PSA of 15.6% and PSA-ACT of 26.7% yielded 95% sensitivity [17]. The F-PSA-to-PSA ratio does not correlate to grade or stage of cancer.
Catechin levels
Extraction of Catechins from Prostate Tissue, plasma and urine samples
Number of pts with adverse events as a measure of safety and tolerability
AEs will be recorded from the date the informed consent document is signed until the day of surgery. Liver function tests including the Hepatic Function Panel [Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferace (AST), total and direct Bilirubin], as well as amylase and lipase tests will be monitored at baseline and every four (4) weeks for the duration of the study.
Changes in the levels of total (t) PSA
PSA exists in the serum in different molecular forms and that the proportion of "complexed" PSA (PSA-ACT) to "free" PSA(F-PSA) is higher in prostate cancer patients [16]. F-PSA-to-PSA ratio remains constant in men without prostate cancer while total PSA increases. This F-PSA to-PSA ratio is useful diagnostic tool with borderline total PSA values (4.0 to 10.0 ng/mL); additionally values of 20% to 25% F-PSA eliminates 1/3 of biopsies in some studies; and F-PSA of 15.6% and PSA-ACT of 26.7% yielded 95% sensitivity [17]. The F-PSA-to-PSA ratio does not correlate to grade or stage of cancer.
Full Information
NCT ID
NCT01340599
First Posted
April 20, 2011
Last Updated
March 14, 2012
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01340599
Brief Title
Defined Green Tea Catechin Extract in Treating Patients With Localized Prostate Cancer Undergoing Surgery
Official Title
Phase II, Randomized, Double Blind, Placebo Controlled Pilot Study of Polyphenon E in Men With Localized Prostate Cancer Scheduled to Undergo Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (Polyphenon E)
Arm Type
Experimental
Arm Description
Patients receive defined green tea catechin extract PO once daily QD for 4-10 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo radical prostatectomy between days 28-70.
Arm Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
defined green tea catechin extract
Other Intervention Name(s)
Polyphenon E
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Other Intervention Name(s)
immunohistochemistry
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
immunoenzyme technique
Other Intervention Name(s)
immunoenzyme techniques
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo radical prostatectomy
Intervention Type
Other
Intervention Name(s)
high performance liquid chromatography
Other Intervention Name(s)
HPLC
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
mass spectrometry
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
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
Time Frame
Baseline and at or after 6 weeks of treatment
Secondary Outcome Measure Information:
Title
Changes in the levels of free (f) PSA
Description
PSA exists in the serum in different molecular forms and that the proportion of "complexed" PSA (PSA-ACT) to "free" PSA(F-PSA) is higher in prostate cancer patients [16]. F-PSA-to-PSA ratio remains constant in men without prostate cancer while total PSA increases. This F-PSA to-PSA ratio is useful diagnostic tool with borderline total PSA values (4.0 to 10.0 ng/mL); additionally values of 20% to 25% F-PSA eliminates 1/3 of biopsies in some studies; and F-PSA of 15.6% and PSA-ACT of 26.7% yielded 95% sensitivity [17]. The F-PSA-to-PSA ratio does not correlate to grade or stage of cancer.
Time Frame
After 0, 4, and 6 weeks
Title
Catechin levels
Description
Extraction of Catechins from Prostate Tissue, plasma and urine samples
Time Frame
At baseline, 4 weeks after supplementation, and at time of surgery
Title
Number of pts with adverse events as a measure of safety and tolerability
Description
AEs will be recorded from the date the informed consent document is signed until the day of surgery. Liver function tests including the Hepatic Function Panel [Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferace (AST), total and direct Bilirubin], as well as amylase and lipase tests will be monitored at baseline and every four (4) weeks for the duration of the study.
Time Frame
At baseline and every 4 weeks
Title
Changes in the levels of total (t) PSA
Description
PSA exists in the serum in different molecular forms and that the proportion of "complexed" PSA (PSA-ACT) to "free" PSA(F-PSA) is higher in prostate cancer patients [16]. F-PSA-to-PSA ratio remains constant in men without prostate cancer while total PSA increases. This F-PSA to-PSA ratio is useful diagnostic tool with borderline total PSA values (4.0 to 10.0 ng/mL); additionally values of 20% to 25% F-PSA eliminates 1/3 of biopsies in some studies; and F-PSA of 15.6% and PSA-ACT of 26.7% yielded 95% sensitivity [17]. The F-PSA-to-PSA ratio does not correlate to grade or stage of cancer.
Time Frame
After 0, 4, and 6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Gupta
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Defined Green Tea Catechin Extract in Treating Patients With Localized Prostate Cancer Undergoing Surgery
We'll reach out to this number within 24 hrs