Clinical Trial of Green Tea Catechins in Men on Active Surveillance (NCT04300855) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Clinical Trial of Green Tea Catechins in Men on Active Surveillance
United States115 participantsStarted 2020-08-21
Plain-language 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
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hig…
What they're measuring
1
Rate of Progression to Prostate Cancer (PCa)
Timeframe: 24 months
Trial details
NCT IDNCT04300855
SponsorH. Lee Moffitt Cancer Center and Research Institute