Clinical trial NCT04300855: Clinical Trial of Green Tea Catechins in Men on Active Surveillance
Official title: Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: Prostate
Green Tea
Green Tea Catechins
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-09
Enrollment: 115
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants participating in the study will be randomized 2:1 (2 study agent: 1 placebo) to receive Sunphenon® 90D (405 mg EGCG BID) or placebo.
Primary purpose: OTHER

Brief 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


Eligibility 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
* 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.

Primary outcomes:
measure: Rate of Progression to Prostate Cancer (PCa)
timeFrame: 24 months
Secondary outcomes:
measure: Occurrence of Adverse Events per Study Arm
timeFrame: Base line to 24 months
measure: Adherence of Green Tea Catechins vs.Placebo
timeFrame: Baseline to 24 months
measure: Acceptability of Green Tea Catechins vs.Placebo
timeFrame: Baseline to 24 months
measure: Change in (prostate-specific antigen) PSA and PSA kinetics
timeFrame: Baseline to 24 months
measure: Change in gene expression panel
timeFrame: Baseline to 24 months
measure: Proportion of men with no cancer
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
Study officials:
affiliation: Moffitt Cancer Center
name: Nagi Kumar, PhD RD FADA
role: PRINCIPAL_INVESTIGATOR
References: