Prostate CancerPhase 2NCT00676780
Green Tea Extract and Prostate Cancer
A Phase 2 study testing Polyphenon E (EGCG) in people with Prostate Cancer, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Polyphenon E (EGCG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recent biopsy positive for prostate cancer
- scheduled for prostatectomy
- must be able to swallow capsules
- Palpable mass by digital rectal examination (DRE)
- Ability to give informed consent and willingness to adhere to study protocol
- Age ≥ 18 years and less than 75
Who cannot join
- abnormal liver function
- Prior hormonal or surgical therapy for prostate cancer
- Liver or kidney problems that would interfere with metabolism of study drug
- Any condition that would hamper informed consent or ability to comply with study protocol
- Participation in another research study in the last three months
- Known malignancy at any site other than prostate
- Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Health Sciences Center
Shreveport, Louisiana, 71103
About this study
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
Read the detailed description
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between prostate biopsy and radical prostatectomy in men with recently diagnosed prostate cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.
The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.
1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with prostate cancer 1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with prostate cancer 1.3 Determine the effects of Polyphenon E on MAPK activation in patients with prostate cancer 1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with prostate cancer 1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with prostate cancer 1.6 Determine the effects of Polyphenon E on serum Prostate Specific Antigen (PSA) in patients with prostate cancer 1.7 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3), Hepatocyte Growth Factor HGF 1.8 Evaluate the safety and tolerability of Polyphenon E in this subject population
- Conditions
- Prostate Cancer
- Being tested
- Polyphenon E (EGCG)
- Keywords
- EGCG, polyphenols, biomarkers, prostate specific antigen
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenon E (EGCG)Drug
Also called Polyphenon E
4 capsules daily with a meal for the duration of the study
| Study group | Role | What they receive |
|---|---|---|
| ECGC Extract | Experimental | Single arm for a phase II study Receives: Drug: Polyphenon E (EGCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
Measured: Baseline and 6 weeks
Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.
Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.
Measured: Baseline and 6 weeks.
Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.
Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startMay 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Collaborators
- Polyphenon Pharma
- Responsible party
- Principal investigator, Jerry McLarty, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Jerry W McLarty, Ph.D., Principal investigator, LSUHSC Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676780
- Sponsor's protocol ID
- H04-176
- Status last verified
- Jun 2012
- First submitted
- 9 May 2008
- Last updated
- 8 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McLarty J, Bigelow RL, Smith M, Elmajian D, Ankem M, Cardelli JA. Tea polyphenols decrease serum levels of prostate-specific antigen, hepatocyte growth factor, and vascular endothelial growth factor in prostate cancer patients and inhibit production of hepatocyte growth factor and vascular endothelial growth factor in vitro. Cancer Prev Res (Phila). 2009 Jul;2(7):673-82. doi: 10.1158/1940-6207.CAPR-08-0167. Epub 2009 Jun 19.
PubMed 19542190
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea Extract and Prostate Cancer
- ClinicalTrials.gov ID
- NCT00676780
- Acronym / sponsor ID
- H04-176
- Conditions
- Prostate Cancer
- Keywords
- EGCG, polyphenols, biomarkers, prostate specific antigen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Collaborators
- Polyphenon Pharma
- Study start
- May 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Posted 8 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
Detailed description
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between prostate biopsy and radical prostatectomy in men with recently diagnosed prostate cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.
The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.
1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with prostate cancer 1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with prostate cancer 1.3 Determine the effects of Polyphenon E on MAPK activation in patients with prostate cancer 1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with prostate cancer 1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with prostate cancer 1.6 Determine the effects of Polyphenon E on serum Prostate Specific Antigen (PSA) in patients with prostate cancer 1.7 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3), Hepatocyte Growth Factor HGF 1.8 Evaluate the safety and tolerability of Polyphenon E in this subject population
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECGC Extract | Experimental | Drug: Polyphenon E (EGCG)Single arm for a phase II study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- recent biopsy positive for prostate cancer
- scheduled for prostatectomy
- must be able to swallow capsules
- Palpable mass by digital rectal examination (DRE)
- Ability to give informed consent and willingness to adhere to study protocol
Key exclusion criteria (7 listed)
- abnormal liver function
- Prior hormonal or surgical therapy for prostate cancer
- Liver or kidney problems that would interfere with metabolism of study drug
- Any condition that would hamper informed consent or ability to comply with study protocol
- Participation in another research study in the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyphenon E (EGCG)Also: Polyphenon E4 capsules daily with a meal for the duration of the study | Drug | ECGC Extract |
Primary outcome
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
Time frame: Baseline and 6 weeks
Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.
Time frame: Baseline and 6 weeks.
Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.
Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.
Time frame: Baseline and 6 weeks
Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19542190McLarty J, Bigelow RL, Smith M, Elmajian D, Ankem M, Cardelli JA. Tea polyphenols decrease serum levels of prostate-specific antigen, hepatocyte growth factor, and vascular endothelial growth factor in prostate cancer patients and inhibit production of hepatocyte growth factor and vascular endothelial growth factor in vitro. Cancer Prev Res (Phila). 2009 Jul;2(7):673-82. doi: 10.1158/1940-6207.CAPR-08-0167. Epub 2009 Jun 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry W McLarty, Ph.D. principal investigator
LSUHSC Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polyphenon E (EGCG) in people with Prostate Cancer, run by Louisiana State University Health Sciences Center Shreveport 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 8 Aug 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. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Serum Prostate Specific Antigen (PSA) of Prostate Cancer (time frame: Baseline and 6 weeks). The study lists 3 primary outcomes in all. 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 NCT00676780, 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 Aug 2012; AzTrials last refreshed its copy on 1 Nov 2026.