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Clinical Trial of Green Tea Catechins in Men on Active Surveillance | Clinical Trials | Clareo Health

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Clinical Trial of Green Tea Catechins in Men on Active Surveillance

Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)

NCT04300855•H. Lee Moffitt Cancer Center and Research Institute

Summary

This randomized double-blinded Phase II clinical trial will evaluate the bioavailability, safety, effectiveness and validate the mechanism by which a standardized formulation of whole Green Tea Catechin, (Sunphenon® 90D) containing 405 mgs vs. Placebo, administered for 24 months in a cohort of men with low to intermediate grade prostate managed on active surveillance

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•18 years of age or older
•Biopsy-proven (consisting of ≥ 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core (TRUS or/and mpMRI/TRUS fusion), Gleason score (3+3) or predominant Gleason pattern 3 (3+4), ≤ 33% of biopsy cores, and ≤50% involvement of any biopsy core (Participant meets all criteria for Active Surveillance as determined by MD)
•Willing to start or continue on active surveillance
•Baseline/screening serum PSA \<10 ng/mL
•No other prior treatment for PCa, including focal therapy
•ECOG performance status 0-1
•No history of renal or hepatic disease, including history of hepatitis B and C
•Meet hematological eligibility parameters (Neutrophil count ≥ 1,200/mm3 (≥1.2 k/μL), Stable platelet count ≥ 75,000/mm3 (≥ 75k/μL) Hepatic and renal function eligibility parameters, serum total Bilirubin ≤ULN (ULN: 1.2 mg/dl) (or ≤3.0 mg/dL for patients with Gilbert's syndrome), AST or ALT \<1.5x ULN and Serum creatinine ≤1.5 x ULN
•Willing to abstain from consumption of any supplements containing GTC
•Willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week
+2 more criteria

Exclusion Criteria

•Have had prior treatment for PCa by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy)
•Men who are currently treated or those treated in the past 3 months prior to day of randomization with 5- alpha-reductase inhibitors (e.g., finasteride, dutasteride)
•Participants who have PCa with distant metastases
•Participants who have been treated with: hormone therapy, immunotherapy, chemotherapy and/or radiation, for any malignancies within the past 2 years prior to registration.Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. All patients with metastatic disease will be excluded
•Participants may not be receiving any other investigational agents
•History of allergic reactions attributed to tea or compounds of similar chemical or biologic composition to green tea extracts.

Locations (2)

Moffitt Cancer Center

Tampa, Florida, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Key Dates

Start Date

August 21, 2020

Primary Completion Date

February 27, 2027

Completion Date

February 27, 2027

Last Updated

February 2, 2026

Enrollment

115

ACTUAL participants

Conditions

Prostate CancerProstate Adenocarcinoma

Interventions

Sunphenon

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial of Green Tea Catechins in Men on Active Surveillance

Inclusion Criteria

Exclusion Criteria

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