Clinical Trial of Green Tea Catechins in Men on Active Surveillance

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Treatments: Drug: Placebo; Drug: Sunphenon

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04300855

1R01CA235032-01A1 (U.S. NIH Grant/Contract)

MCC-20056

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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
• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 2 patient groups, including a placebo group

Sunphenon® 90D

Experimental group

Description:

Participants will be administered a standardized formulation of whole Green Tea Catechin for 24 months. The daily dose of Green Tea Catechin will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.

Treatment:

Drug: Sunphenon

Placebo

Placebo Comparator group

Description:

Participants will be administered a placebo for 24 months. The daily dose of placebo will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.

Treatment:

Drug: Placebo