Green tea extract tested to keep prostate cancer in check
NCT ID NCT04300855
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily dose of green tea catechins (a natural compound) can prevent low- to intermediate-risk prostate cancer from getting worse in men who are not receiving immediate treatment. Over 24 months, 115 men will receive either the green tea extract or a placebo. The goal is to see if the extract can delay or avoid the need for more aggressive treatments like surgery or radiation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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115 people
The number who actually took part.
- Started
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Aug 2020
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * Willing to discontinue current vitamin/mineral supplement use and use one provided by study * Willing to take study agent or placebo at the dose specified with meals. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a 10-Hour eating window fight cancer fatigue?