- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (Polyphenon E)
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.
|
Ancillary studies
Correlative studies
Other Names:
Correlative studies
Undergo radical prostatectomy
Correlative studies
Other Names:
Correlative studies
Other Names:
Given PO
Other Names:
|
Placebo Comparator: Arm II (placebo)
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.
|
Ancillary studies
Correlative studies
Other Names:
Correlative studies
Given PO
Other Names:
Undergo radical prostatectomy
Correlative studies
Other Names:
Correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline and at or after 6 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the levels of free (f) PSA
Time Frame: After 0, 4, and 6 weeks
|
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.
|
After 0, 4, and 6 weeks
|
Catechin levels
Time Frame: At baseline, 4 weeks after supplementation, and at time of surgery
|
Extraction of Catechins from Prostate Tissue, plasma and urine samples
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At baseline, 4 weeks after supplementation, and at time of surgery
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Number of pts with adverse events as a measure of safety and tolerability
Time Frame: At baseline and every 4 weeks
|
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.
|
At baseline and every 4 weeks
|
Changes in the levels of total (t) PSA
Time Frame: After 0, 4, and 6 weeks
|
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.
|
After 0, 4, and 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sanjay Gupta, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Neuroprotective Agents
- Protective Agents
- Antioxidants
- Anticarcinogenic Agents
- Antimutagenic Agents
- Epigallocatechin gallate
Other Study ID Numbers
- CASE13805
- NCI-2011-00606 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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