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

NCT01340599 | Terminated Phase 2 DMC

• 2 other identifiers: CASE13805NCI-2011-00606
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (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

  Baseline and at or after 6 weeks of treatment

Secondary Outcomes (4)

• Changes in the levels of free (f) PSA

  After 0, 4, and 6 weeks

• Catechin levels

  At baseline, 4 weeks after supplementation, and at time of surgery

• Number of pts with adverse events as a measure of safety and tolerability

  At baseline and every 4 weeks

• Changes in the levels of total (t) PSA

  After 0, 4, and 6 weeks

Study Arms (2)

Arm I (Polyphenon E)

EXPERIMENTAL

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; Other: immunohistochemistry staining method; Other: immunoenzyme technique; Other: questionnaire administration; Procedure: therapeutic conventional surgery; Other: high performance liquid chromatography; Other: mass spectrometry

Arm II (placebo)

PLACEBO COMPARATOR

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; Other: immunohistochemistry staining method; Other: immunoenzyme technique; Other: questionnaire administration; Procedure: therapeutic conventional surgery; Other: high performance liquid chromatography; Other: mass spectrometry

Interventions

high performance liquid chromatography OTHER

Correlative studies

Also known as: HPLC

Arm I (Polyphenon E); Arm II (placebo)

defined green tea catechin extract DIETARY_SUPPLEMENT

Given PO

Also known as: Polyphenon E

Arm I (Polyphenon E)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm I (Polyphenon E); Arm II (placebo)

immunoenzyme technique OTHER

Correlative studies

Also known as: immunoenzyme techniques

Arm I (Polyphenon E); Arm II (placebo)

questionnaire administration OTHER

Ancillary studies

Arm I (Polyphenon E); Arm II (placebo)

therapeutic conventional surgery PROCEDURE

Undergo radical prostatectomy

Arm I (Polyphenon E); Arm II (placebo)

mass spectrometry OTHER

Correlative studies

Arm I (Polyphenon E); Arm II (placebo)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

polyphenon E; Immunohistochemistry; Immunoenzyme Techniques; Chromatography, High Pressure Liquid; Mass Spectrometry

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Immunoassay; Molecular Probe Techniques; Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical

Study Officials

• Sanjay Gupta

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 22, 2011
• Study Start: October 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (1)