A Phase 2 interventional study of Polyphenon E (EGCG) in Prostate Cancer, sponsored by Louisiana State University Health Sciences Center Shreveport. Completed at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-08-08.
Sponsored by Louisiana State University Health Sciences Center Shreveport · Phase 2, Interventional, and Basic science
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
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 33 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Louisiana State University Health Sciences Center Shreveport is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm for a phase II study
Drug: Polyphenon E (EGCG)
4 capsules daily with a meal for the duration of the study
Also known as: Polyphenon E
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 weeks
Patients were recruited from the urology clinic at LSU Health, Shreveport during the period of May 1, 2004 and February 20, 2008.
| Milestone | ECGC Extract, Prostate Cancer |
|---|---|
| Started | 33 |
| Completed | 26 |
| Not completed | 7 |
Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
| ng/mL | ECGC Extract |
|---|---|
| Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer | 0.86 (0.0425 to 2.4675) |
Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.
| pg/mL | ECGC Extract |
|---|---|
| Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer. | 26.8 (-6.315 to 123.38) |
Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.
| pg/mL | ECGC Extract |
|---|---|
| Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer. | 96.67 (27.0837 to 358.7475) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ECGC Extract, Prostate Cancer | — | 1/33 (3%) | 0/33 (0%) |
| Event | ECGC Extract, Prostate Cancer |
|---|---|
| Myocardial InfarctionCardiac disorders | 1/33 |
| Age, Categorical(Participants) | ECGC Extract, Prostate Cancer |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 6 |
| Age Continuous(years) | ECGC Extract, Prostate Cancer |
|---|---|
| Mean | 58.6 ± 7.1 |
| Sex: Female, Male(Participants) | ECGC Extract, Prostate Cancer |
|---|---|
| Female | 0 |
| Male | 33 |
| Region of Enrollment(participants) | ECGC Extract, Prostate Cancer |
|---|---|
| United States | 33 |
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Louisiana State University Health Sciences Center Shreveport