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Green Tea Extract for Prostate Cancer

Phase 2

Recruiting

Led By Nagi Kumar, PhD, RD, FADA

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Gleason score (3+3) or predominant Gleason pattern 3 (3+4)

Must not have

Prior treatment for PCa by surgery, irradiation, local ablative, or androgen-deprivation therapy

Treatment with hormone therapy, immunotherapy, chemotherapy, and/or radiation for any malignancies within the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Summary

This trial will evaluate the safety, effectiveness and bioavailability of a standardized Green Tea Catechin formulation given over 24 months to men with low- to intermediate-grade prostate managed on active surveillance.

Who is the study for?

Men 18 or older with low to intermediate grade prostate cancer managed on active surveillance can join. They must have a PSA <10 ng/mL, no history of serious kidney or liver disease, and agree to limit tea intake and not use other vitamin/mineral supplements during the trial. Prior treatments for prostate cancer or recent use of certain medications disqualify participation.

What is being tested?

The study is testing Sunphenon (a green tea extract) against a placebo over two years to see if it's safe and effective in men with prostate cancer who are being closely monitored but not actively treated. The trial randomly assigns participants to either the supplement or placebo group without them knowing which one they're getting.

What are the potential side effects?

While specific side effects aren't listed, potential reactions could include those commonly associated with dietary supplements such as digestive discomfort, allergic reactions for those sensitive to tea components, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My prostate cancer has a Gleason score of 3+3 or 3+4.

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I am willing to stop my current vitamins and use those provided by the study.

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My prostate cancer was confirmed by a biopsy.

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I have not received any treatment for prostate cancer before.

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I am fully active or can carry out light work.

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I have no history of kidney or liver diseases, including hepatitis B or C.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for prostate cancer, including surgery or hormone therapy.

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I haven't had cancer treatment like hormone therapy, immunotherapy, chemotherapy, or radiation in the last 2 years.

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My prostate cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Progression to Prostate Cancer (PCa)

Secondary study objectives

Acceptability of Green Tea Catechins vs.Placebo

Adherence of Green Tea Catechins vs.Placebo

Change in (prostate-specific antigen) PSA and PSA kinetics

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sunphenon® 90DExperimental Treatment1 Intervention

Participants will be administered a standardized formulation of whole Green Tea Catechin for 24 months. The daily dose of Green Tea Catechin will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be administered a placebo for 24 months. The daily dose of placebo will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.

0 / 10Eligibility criteria met