Prostate Cancer
Conditions
Keywords
EGCG, polyphenols, biomarkers, prostate specific antigen
Brief summary
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
Interventions
DRUGPolyphenon E (EGCG)
4 capsules daily with a meal for the duration of the study
Sponsors
Polyphenon Pharma
Louisiana State University Health Sciences Center Shreveport
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer | 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. | 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. | Baseline and 6 weeks | Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the urology clinic at LSU Health, Shreveport during the period of May 1, 2004 and February 20, 2008.
Pre-assignment details
Exclusion criterias were determined before enrollment process.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | ECGC Extract, Prostate Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age Continuous | 58.6 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 1 / 33 |
Outcome results
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.
Time frame: Baseline and 6 weeks
Population: Number of participants for analysis was determined per protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ECGC Extract | Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer. | 96.67 pg/mL |
Comparison: Null hypothesis is no change, i.e. median change = 0.0p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline and 6 weeks
Population: The number of participants for analysis was determined per protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ECGC Extract | Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer | 0.86 ng/mL |
p-value: =0.027Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline and 6 weeks.
Population: The number of participants for analysis was determined per protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ECGC Extract | Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer. | 26.8 pg/mL |
p-value: 0.023Wilcoxon (Mann-Whitney)