Green Tea Extract in Treating Patients With Low-Risk Prostate Cancer

NCT01928485 | Terminated Phase 2 Results DMC

• 2 other identifiers: CASE6812NCI-2013-01372
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial studies how well green tea extract works in treating patients with low-risk prostate cancer. Green tea 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 (7)

• Total-PSA (tPSA) Levels

  tPSA serum levels

  From baseline at 52 weeks

• Changes in the f/tPSA Ratio

  The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

  From baseline at 52 weeks

• Changes in IGF-I Levels

  The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

  Baseline to 52 weeks

• Changes in the IGF-I/fPSA Ratio

  The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

  Baseline up to 52 weeks

• Changes in the Level of IGFBP-3

  The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

  Baseline to 52 weeks

• Changes in the Level of VEGF

  The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

  Baseline up to 52 weeks

• Changes in the Levels of Free-PSA (f-PSA)

  The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

  from baseline at 52 weeks

Secondary Outcomes (15)

• Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA)

  Up to 52 weeks

• Effects of Oral Ingestion of Green Tea Extract on Levels of Ki-67

  Up to 52 weeks

• Effects of Oral Ingestion of Green Tea Extract on Levels of CD34

  Up to 52 weeks

• Effects of Oral Ingestion of Green Tea Extract on Levels of M30 Apoptosense in the Prostate Tissue

  Up to 52 weeks

• Effects of Oral Ingestion of Sunphenon 90 DCF-T on Histologic Findings in Prostate Tissue Such as Nuclear Measurements Viz. Shape, Size and Texture

  Up to 52 weeks

Study Arms (2)

Arm A (active surveillance)

ACTIVE COMPARATOR

Patients undergo active surveillance for 52 weeks.

Other: active surveillance; Other: laboratory biomarker analysis; Other: Questionnaire Administration

Arm B (Sunphenon)

EXPERIMENTAL

Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Sunphenon; Other: laboratory biomarker analysis; Other: Questionnaire Administration

Interventions

active surveillance OTHER

Undergo active surveillance

Arm A (active surveillance)

Sunphenon DRUG

Given PO

Also known as: Green tea polyphenols, Green tea extract, Sunphenon 90DCD-T

Arm B (Sunphenon)

laboratory biomarker analysis OTHER

Correlative studies

Arm A (active surveillance); Arm B (Sunphenon)

Questionnaire Administration OTHER

Ancillary studies

Also known as: The Expanded Prostate Cancer Index Composite (EPIC-26), American Urological Association (AUA) symptom index, Quality of Life (SF-12), Food Questionnaire

Arm A (active surveillance); Arm B (Sunphenon)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be males with histologically confirmed and clinically localized low-grade and low-volume prostate cancer demonstrated at the time of initial diagnosis
• Prostate biopsy must be positive for cancer: clinically localized T1c or T2a, PSA ≤ 10, Gleason ≤ 6 at the time of initial diagnosis. As the intent of serial biopsy is to ensure that the disease has not progressed to the stage or grade of requiring treatment, the presence of a negative biopsy following an initial positive biopsy (coupled with clinically localized T1c or T2a PSA ≤10 and Gleason ≤6 for a patient who has had no treatment, will not render the patient ineligible. If the consecutive biopsy is either negative, or if positive and remains clinically localized T1c or T2a, PSA≤10 and Gleason ≤6, the patient is eligible
• Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Advodart, and anti-inflammatory agents
• 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 for the duration of the study
• Subjects must have newly diagnosed (within 1 year), previously untreated prostate cancer without other malignancy; therefore, no prior therapies are permitted
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) ≤ institutional upper limit of normal
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ institutional upper limit of normal
• Serum creatinine within normal institutional limits
• Subject must be willing to limit alcohol to moderate use which is defined as: up to one drink a day for women or two drinks a day for men; examples of one drink include:
• Beer: 12 fluid ounces (355 milliliters)
• Wine: 5 fluid ounces (148 milliliters)
• Distilled spirits (80 proof): 1.5 fluid ounces (44 milliliters)

You may not qualify if:

• Patients who are receiving any other investigational agents
• Patients with known concurrent malignancy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Sunphenon 90 DCF-T or other agents used in this study
• Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization; or concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients who have received prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy
• Signs or symptoms of progressive or uncontrolled liver disease
• Known malignancy at any site within the last two 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
• Patients with a known history of Gilbert's syndrome

Sponsors & Collaborators

• Sanjay Gupta PhD: lead

Study Sites (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting; Sunphenon; Tea; Quality of Life

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)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Lee Ponsky
• Organization: Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

lee.ponsky@uhhospitals.org

+1 216-844-4831

Study Officials

• Lee Ponsky, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 26, 2013
• Study Start: August 30, 2013
• Primary Completion: October 5, 2016
• Study Completion: November 7, 2016
• Last Updated: October 22, 2020
• Results First Posted: March 3, 2020

Record last verified: 2020-09

Locations

US (1)