Clinical Trial of Green Tea Catechins in Men on Active Surveillance

• Status: Recruiting
• Trial end date: 2024-04-15
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Epigallocatechin gallate

Criteria

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

• 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.

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 treated 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.