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Stage I Prostate CancerPhase 2NCT01340599

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

A Phase 2 study testing defined green tea catechin extract, immunohistochemistry staining method and immunoenzyme technique in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years, men only
What is being tested?
defined green tea catechin extract, immunohistochemistry staining method and immunoenzyme technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
1 siteUnited States
Study dates
Oct 2006to Apr 2007
Phase
Phase 2
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 45 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Cleveland, Ohio, 44106

Other trials in United States

About this study

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

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.

Read the detailed description

OBJECTIVES:

  1. 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).

  1. 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.

Being tested
defined green tea catechin extract, placebo, immunohistochemistry staining method, immunoenzyme technique, questionnaire administration
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 PO

  • placeboOther

    Also called PLCB

    Given PO

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Correlative studies

  • immunoenzyme techniqueOther

    Also called immunoenzyme techniques

    Correlative studies

  • questionnaire administrationOther

    Ancillary studies

  • therapeutic conventional surgeryProcedure or surgery

    Undergo radical prostatectomy

  • high performance liquid chromatographyOther

    Also called HPLC

    Correlative studies

  • mass spectrometryOther

    Correlative studies

Study groups in NCT01340599
Study groupRoleWhat they receive
Arm I (Polyphenon E)ExperimentalPatients 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.
Receives: 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 comparatorPatients 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.
Receives: Other: placebo; Other: immunohistochemistry staining method; Other: immunoenzyme technique; Other: questionnaire administration; Procedure: therapeutic conventional surgery; Other: high performance liquid chromatography; Other: mass spectrometry

What is being measured

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

  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

    Measured: Baseline and at or after 6 weeks of treatment

Secondary outcomes (4)

  1. Changes in the levels of free (f) PSA

    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.

    Measured: After 0, 4, and 6 weeks

  2. Catechin levels

    Extraction of Catechins from Prostate Tissue, plasma and urine samples

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

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

    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.

    Measured: At baseline and every 4 weeks

  4. Changes in the levels of total (t) PSA

    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.

    Measured: After 0, 4, and 6 weeks

Timeline

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

  1. First posted22 Apr 2011 (estimated)
  2. Study startOct 2006
  3. Primary completionApr 2007
  4. Study completionApr 2007

Why it stopped: Slow accrual

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01340599
Sponsor's protocol ID
CASE13805
Other IDs
NCI-2011-00606
Status last verified
Mar 2012
First submitted
20 Apr 2011
Last updated
15 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing defined green tea catechin extract, immunohistochemistry staining method and immunoenzyme technique in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Case Comprehensive Cancer Center 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?

The sponsor lists 5 inclusion and 14 exclusion criteria. 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: stopped early, as of the sponsor's last update on 15 Mar 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Slow accrual). Results are not available in the source record.

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?

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). 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 NCT01340599.

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 15 Mar 2012; AzTrials last refreshed its copy on 6 Nov 2026.

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