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Trial record 33 of 278 for:    prostate cancer AND localized | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT01340599
Recruitment Status : Terminated (Slow accrual)
First Posted : April 22, 2011
Last Update Posted : March 15, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Dietary Supplement: defined green tea catechin extract Other: placebo Other: immunohistochemistry staining method Other: immunoenzyme technique Other: questionnaire administration Procedure: therapeutic conventional surgery Other: high performance liquid chromatography Other: mass spectrometry Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : October 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.
Dietary Supplement: defined green tea catechin extract
Given PO
Other Name: Polyphenon E

Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry

Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques

Other: questionnaire administration
Ancillary studies

Procedure: therapeutic conventional surgery
Undergo radical prostatectomy

Other: high performance liquid chromatography
Correlative studies
Other Name: HPLC

Other: mass spectrometry
Correlative studies

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.
Other: placebo
Given PO
Other Name: PLCB

Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry

Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques

Other: questionnaire administration
Ancillary studies

Procedure: therapeutic conventional surgery
Undergo radical prostatectomy

Other: high performance liquid chromatography
Correlative studies
Other Name: HPLC

Other: mass spectrometry
Correlative studies




Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340599


Locations
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United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sanjay Gupta Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01340599     History of Changes
Other Study ID Numbers: CASE13805
NCI-2011-00606 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents