Prostate Cancer Clinical Trial
Clinical Trial of Green Tea Catechins in Men on Active Surveillance
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
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
Screening serum PSA <10 ng/mL or PSAD <0.15 ng/mL/g
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.
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
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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There are 2 Locations for this study
Tampa Florida, 33612, United States More Info
(813) 745 6885
Westwood Kansas, 66205, United States More Info
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