Trial Outcomes & Findings for Green Tea Extract and Prostate Cancer (NCT NCT00676780)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2012-08-08

Participant Flow

Patients were recruited from the urology clinic at LSU Health, Shreveport during the period of May 1, 2004 and February 20, 2008.

Exclusion criterias were determined before enrollment process.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	33
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Green Tea Extract and Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ECGC Extract, Prostate Cancer n=33 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	58.6 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: The number of participants for analysis was determined per protocol.

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

Outcome measures

Outcome measures
Measure	ECGC Extract n=26 Participants 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.
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer	0.86 ng/mL Interval 0.0425 to 2.4675

PRIMARY outcome

Timeframe: Baseline and 6 weeks.

Population: The number of participants for analysis was determined per protocol.

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

Outcome measures

Outcome measures
Measure	ECGC Extract n=26 Participants 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.
Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.	26.8 pg/mL Interval -6.315 to 123.38

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: Number of participants for analysis was determined per protocol.

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

Outcome measures

Outcome measures
Measure	ECGC Extract n=26 Participants 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.
Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.	96.67 pg/mL Interval 27.0837 to 358.7475

Adverse Events

ECGC Extract, Prostate Cancer

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ECGC Extract, Prostate Cancer n=33 participants at risk 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.
Cardiac disorders Myocardial Infarction	3.0% 1/33 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jerry W. McLarty, Ph.D.

LSUShreveport

Phone: (318)813-1446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place