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| Name | Class |
|---|---|
| Polyphenon Pharma | UNKNOWN |
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The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECGC Extract | Experimental | Single arm for a phase II study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyphenon E (EGCG) | Drug | 4 capsules daily with a meal for the duration of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer | Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment. | 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. | 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. | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry W McLarty, Ph.D. | LSUHSC Shreveport | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSU Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19542190 | Result | 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. |
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Exclusion criterias were determined before enrollment process.
Patients were recruited from the urology clinic at LSU Health, Shreveport during the period of May 1, 2004 and February 20, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | ECGC Extract, Prostate Cancer | Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ECGC Extract, Prostate Cancer | Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer | Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment. | The number of participants for analysis was determined per protocol. | Posted | Median | Inter-Quartile Range | ng/mL | Baseline and 6 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ECGC Extract, Prostate Cancer | Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment | Subject suffered a heart attack prior to surgery procedure. Determined to be not related to study drug. |
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Patient compliance was an issue.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerry W. McLarty, Ph.D. | LSUShreveport | (318)813-1446 | jmclar@lsuhsc.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C472086 | polyphenon E |
| C045651 | epigallocatechin gallate |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Primary | 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. | The number of participants for analysis was determined per protocol. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline and 6 weeks. |
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|
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| Primary | Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer. | Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment. | Number of participants for analysis was determined per protocol. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline and 6 weeks |
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| 1 |
| 33 |
| 0 |
| 33 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |