Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Herbal and Botanical

All Drugs and Chemicals

4 capsules daily with a meal for the duration of the study

Polyphenon E (EGCG)

Jerry W McLarty, Ph.D.

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

Green Tea Extract and Prostate Cancer

Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.

Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.

Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.

Polyphenon Pharma

Louisiana State University Health Sciences Center Shreveport

Professor

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.

ECGC Extract, Prostate Cancer

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Jerry W. McLarty, Ph.D.

Single arm for a phase II study of the effects of Epigallocatechin Gallate (ECGC) polyphenol extract from green tea on biomarkers in patients with prostate cancer.

ECGC Extract

The number of participants for analysis was determined per protocol.

Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer

Single arm for a phase II study of the effects of ECGC polyphenol extract from green tea on biomarkers in patients with prostate cancer.

Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.

Null hypothesis is no change, i.e. median change = 0.0

Epigallocatechin Gallate (ECGC) Single arm for a phase II study.

Number of participants for analysis was determined per protocol.

Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.

Overall Study

Symptoms and General Pathology

Adenocarcinoma

Body Weight

Weight Loss

Body Weight Changes

Other Dietary Supplements

Omega 3 Fatty Acid

English Walnut

Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks

walnuts

usual diet

phone counseling with dietitian

Yunhee Choi-Kuaea, MSW

Stephen Freedland, MD

Aubrey Jarman, RD

This is a randomized control trial testing the effect of walnut supplementation on prostate cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo RP. Patients consented to the study will be randomly assigned to either continue their usual diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their consent date and the date for RP.

The overall objective of this study is to test the effect of walnuts added to a usual diet on prostate cancer progression as measured by Ki67 expression in the prostate tissues. Subjects will be randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts daily. The baseline visit will occur in conjunction with a standard of care visit post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled date of the standard of care radical prostatectomy (RP), and the final visit will occur in conjunction with a standard of care visit prior to RP.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Green Tea Extract and Prostate Cancer	NCT00676780	Prostate Cancer	Polyphenon E (E...	18 Years - 75 Years	Louisiana State University Health Sciences Center Shreveport
Green Tea Extract and Prostate Cancer	NCT00676780	Prostate Cancer	Polyphenon E (E...	18 Years - 75 Years	Louisiana State University Health Sciences Center Shreveport
Green Tea Extract and Prostate Cancer	NCT00676780	Prostate Cancer	Polyphenon E (E...	18 Years - 75 Years	Louisiana State University Health Sciences Center Shreveport
WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy	NCT03824652	Prostate Cancer	walnuts usual diet phone counselin...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for polyphenols

Every month we try and update this database with for polyphenols cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for polyphenols

Every month we try and update this database with for polyphenols cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for polyphenols cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.