Clinical Trial of Green Tea Catechins in Men on Active Surveillance

NCT04300855 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: MCC-200561R01CA235032-01A1
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

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

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

Prostate; Green Tea; Green Tea Catechins

Outcome Measures

Primary Outcomes (1)

• Rate of Progression to Prostate Cancer (PCa)

  Number of participants with clinical progression defined as a composite outcome on repeat prostate biopsy \>33% of biopsy cores positive for cancer or \>50% of any biopsy tissue core positive for cancer or adverse reclassification of Gleason sum \>3+3 or \>3+4 respectively at end of study biopsy

  24 months

Secondary Outcomes (6)

• Occurrence of Adverse Events per Study Arm

  Base line to 24 months

• Adherence of Green Tea Catechins vs.Placebo

  Baseline to 24 months

• Acceptability of Green Tea Catechins vs.Placebo

  Baseline to 24 months

• Change in (prostate-specific antigen) PSA and PSA kinetics

  Baseline to 24 months

• Change in gene expression panel

  Baseline to 24 months

Study Arms (2)

Sunphenon® 90D

EXPERIMENTAL

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.

Drug: Sunphenon

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Sunphenon DRUG

The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months

Also known as: Green Tea Catechin

Sunphenon® 90D

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sunphenon

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nagi Kumar, PhD RD FADA

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: August 21, 2020
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): February 27, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (2)