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Adenocarcinoma of the ProstatePhase 1NCT00459407

Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate

A Phase 1 study testing defined green tea catechin extract, immunohistochemistry staining method and immunoenzyme technique in people with Adenocarcinoma of the Prostate and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
defined green tea catechin extract, immunohistochemistry staining method and immunoenzyme technique
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
Mar 2007to Aug 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Criteria:

  • Biopsy-proven adenocarcinoma of the prostate meeting the following criteria: organ-confined disease; treatable by prostatectomy
  • PSA < 50 ng/mL
  • ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
  • Bilirubin normal
  • AST and ALT normal
  • Creatinine normal
  • Fertile patients must use effective contraception
  • No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness or social situations that would limit study compliance
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extract
  • No prior therapy for prostate cancer (i.e., hormone therapy, radiation therapy, or surgery)
  • No systemic treatment (chemotherapy) and/or radiation therapy for any malignancy within the past 5 years (excluding nonmelanoma skin cancer or cancer confined to organs with surgical removal as the only treatment)
  • No regular tea consumption (> 6 servings of hot tea or 12 servings of iced tea or equivalent combination per week) within the past month
  • No other concurrent investigational agents
  • No other concurrent consumption of tea or tea-derived products from green, black, or oolong tea

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arizona Cancer Center - Tucson

    Tucson, Arizona, 85724-5024

Other trials in United States

About this study

Official title: Phase Ib Study of Polyphenon E in a Pre-prostatectomy Prostate Cancer Cohort

Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the bioavailability of defined green tea catechin extract in prostate tissue after treatment with defined green tea extract in patients with prostate cancer.

SECONDARY OBJECTIVES:

  1. Determine the effect of this treatment on changes in clusterin levels and matrix metalloproteinase (MMP)-2 and MMP-9 in prostate tissue from these patients.

II. Determine the effect of this treatment on changes in serum insulin-like growth factor (IGF)-1 and IGF binding protein-3 in these patients.

III. Determine the effect of this treatment on changes in oxidative DNA damage in peripheral blood leukocytes in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral defined green tea catechin extract daily for 4-7 weeks.

Arm II: Patients receive oral placebo daily for 4-7 weeks.

All patients undergo surgery one day after the last dose of study agent.

Biopsies are taken at the time of surgery. Plasma and tissue catechin levels are measured with high performance liquid chromatography (HPLC). 8OHdG levels in peripheral blood are measured with HPLC and mass spectometry. Immunohistochemistry is used to measure matrix metalloproteinase (MMP)-2, MMP-9, and clusterin. Insulin-like growth factor (IGF)-1 and IGF binding protein-3 are measured with immunoenzyme techniques.

Being tested
defined green tea catechin extract, placebo, immunohistochemistry staining method, immunoenzyme technique, laboratory biomarker analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • defined green tea catechin extractDietary supplement

    Also called Polyphenon E

    Given orally

  • placeboDrug

    Also called PLCB

    Given orally

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Correlative studies

  • immunoenzyme techniqueOther

    Also called immunoenzyme techniques

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

  • biopsyProcedure or surgery

    Also called biopsies

    Undergo biopsy

  • mass spectrometryOther

    Correlative studies

  • high performance liquid chromatographyOther

    Also called HPLC

    Correlative studies

Study groups in NCT00459407
Study groupRoleWhat they receive
Arm I (green tea catechin extract)ExperimentalPatients receive oral defined green tea catechin extract daily for 4-7 weeks. All patients undergo surgery one day after the last dose of study agent.
Receives: Dietary Supplement: defined green tea catechin extract; Other: immunohistochemistry staining method; Other: immunoenzyme technique; Other: laboratory biomarker analysis; Procedure: biopsy; Other: mass spectrometry; Other: high performance liquid chromatography
Arm II (placebo)Placebo comparatorPatients receive oral placebo daily for 4-7 weeks. All patients undergo surgery one day after the last dose of study agent.
Receives: Drug: placebo; Other: immunohistochemistry staining method; Other: immunoenzyme technique; Other: laboratory biomarker analysis; Procedure: biopsy; Other: mass spectrometry; Other: high performance liquid chromatography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-treatment green tea catechin concentration levels in prostate tissue

    Descriptive statistics will be performed on prostate tissue EGCG within each intervention group. The difference in concentration levels between the two intervention groups will be tested using a two-group t-test at a one-sided 0.05 level of significance. If the distributions are not symmetrical, a non-parametric Wilcoxon test will be considered. The percentage of patients positive for EGCG in prostate tissue will be compared between the intervention groups using a Fisher's exact test of proportions at a one-sided 0.05 level of significance.

    Measured: Up to 6 weeks

Secondary outcomes (4)

  1. Changes in clusterin, matrix metalloproteinase (MMP)-2, and MMP-9 levels

    Will be compared between intervention groups using a two-group t-test with a 0.05 two-sided significance level; with a sample size of 23 patients per group, there will be over 90% power to detect a difference equal to an effect size of 1.0. If the distributions are not symmetrical, a non-parametric Wilcoxon test will be considered. Correlations among the various biomarkers, as well as between post-intervention EGCG concentrations and changes in biomarker levels, will be explored (using Pearson or Spearman Rank correlation coefficients as appropriate).

    Measured: Baseline to post-treatment

  2. Changes in Serum levels of insulin-like growth factor (IGF)-1 and IGF binding protein-3

    Will be compared between intervention groups using a two-group t-test with a 0.05 two-sided significance level; with a sample size of 23 patients per group, there will be over 90% power to detect a difference equal to an effect size of 1.0. If the distributions are not symmetrical, a non-parametric Wilcoxon test will be considered. Correlations among the various biomarkers, as well as between post-intervention EGCG concentrations and changes in biomarker levels, will be explored (using Pearson or Spearman Rank correlation coefficients as appropriate).

    Measured: Baseline to post-treatment

  3. Change in ratio of 8OHdG:dG

    Statistical analysis will focus on the change scores (defined as changes from baseline to post-intervention). Changes in the Polyphenon E group will be compared with those in the placebo group, using a two-sided t-test.

    Measured: Baseline to post-treatment

  4. Change in plasma levels of EGCG

    Will be compared between groups, and the correlation of plasma and prostate tissue levels will be examined; however, plasma levels are expected to be low because of the washout during pre-operative fasting. Additional exploratory analyses will investigate the correlation of EGCG tissue levels with adherence during the intervention period (assessed primarily by capsule counts).

    Measured: Baseline to post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00459407
Sponsor's protocol ID
NCI-2009-00894
Other IDs
HSC # 06-0695-04, N01CN35158, CDR0000538554
Status last verified
Feb 2013
First submitted
9 Apr 2007
Last updated
8 Oct 2014
Results posted
No

Publications

  • Nguyen MM, Ahmann FR, Nagle RB, Hsu CH, Tangrea JA, Parnes HL, Sokoloff MH, Gretzer MB, Chow HH. Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities. Cancer Prev Res (Phila). 2012 Feb;5(2):290-8. doi: 10.1158/1940-6207.CAPR-11-0306. Epub 2011 Nov 1.

    PubMed 22044694

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing defined green tea catechin extract, immunohistochemistry staining method and immunoenzyme technique in people with Adenocarcinoma of the Prostate and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-treatment green tea catechin concentration levels in prostate tissue (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00459407, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2014.

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