Clinical Trial of Green Tea Catechins in Men on Active Surveillance

• ClinicalTrials.gov Identifier: NCT04300855
• Recruitment Status: Recruiting
• First Posted: March 9, 2020
• Last Update Posted: May 24, 2023
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): H. Lee Moffitt Cancer Center and Research Institute

Study Description

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

Condition or disease	Intervention/treatment	Phase
Prostate Cancer; Prostate Adenocarcinoma	Drug: Sunphenon; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)
• Actual Study Start Date: August 21, 2020
• Estimated Primary Completion Date: June 30, 2025
• Estimated Study Completion Date: June 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sunphenon® 90D; 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; The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months; Other Name: Green Tea Catechin
Placebo Comparator: Placebo; 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; Matching placebo

Outcome Measures

Primary Outcome Measures :

1. Rate of Progression to Prostate Cancer (PCa) [ Time Frame: 24 months ]
   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

Secondary Outcome Measures :

1. Occurrence of Adverse Events per Study Arm [ Time Frame: Base line to 24 months ]
   Safety of Green Tea Catechins (GTC) at daily dose (vs. Placebo) as indicated by incidence of adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0, complete blood count (CBC), and complete metabolic panel (CMP) from baseline, month 6, month 12 and month 24 at end of trial, Liver toxicities (LFTs) from baseline, month 3, 6 and every 3 months until end of intervention
2. Adherence of Green Tea Catechins vs.Placebo [ Time Frame: Baseline to 24 months ]
   Adherence based on pill counts and agent logs
3. Acceptability of Green Tea Catechins vs.Placebo [ Time Frame: Baseline to 24 months ]
   Acceptability based on pill counts and agent logs
4. Change in (prostate-specific antigen) PSA and PSA kinetics [ Time Frame: Baseline to 24 months ]
   PSA or PSA density and PSA doubling time at month 12 and at 24 months) from serum at baseline, 6, 12, 18 and month 24
5. Change in gene expression panel [ Time Frame: Baseline to 24 months ]
   Asses change in gene expression panel (Decipher) and a set of 13 biomarker genes known to be overexpressed in PCa from baseline to end of study (EOS) using biopsy tissue
6. Proportion of men with no cancer [ Time Frame: Baseline to 24 months ]
   Assess the proportion of men with no cancer in the post-intervention biopsy

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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 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 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.

Contacts and Locations

Contacts

Contact: Nagi Kumar, PhD, RD, FADA; (813) 745-6885; Nagi.Kumar@moffitt.org

Locations

United States, Florida

Moffitt Cancer Center; Recruiting

Tampa, Florida, United States, 33612

Contact: Zara Kaur (813) 745-1023 Zara.Kaur@moffitt.org

Contact: Nagi Kumar, PhD, RD, FADA (813) 745 6885 Nagi.Kumar@moffitt.org

Sub-Investigator: Julio Pow-Sang, MD

Sub-Investigator: Michael Poch, MD

Sub-Investigator: Brandon Manley, MD

Sub-Investigator: Roger Li, MD

Sub-Investigator: Kosj Yamoah, MD

Sub-Investigator: Kenneth Gage, MD, PhD

Sub-Investigator: Christine Pierce, PhD

Sub-Investigator: Michael Schell, PhD

Sub-Investigator: Jasreman Dhillon, MD

United States, Kansas

University of Kansas Cancer Center; Recruiting

Westwood, Kansas, United States, 66205

Contact: Jillian Montan 913-574-2635 JMontan@kumc.edu

Contact: Lenora Overton 1 913-574-2635 LOverton3@kumc.edu

Principal Investigator: William Parker, MD

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Nagi Kumar, PhD, RD, FADA; Moffitt Cancer Center

More Information

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT04300855
• Other Study ID Numbers: MCC-20056; 1R01CA235032-01A1 ( U.S. NIH Grant/Contract )
• First Posted: March 9, 2020
• Last Update Posted: May 24, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:

Prostate; Green Tea; Green Tea Catechins

Additional relevant MeSH terms:

Adenocarcinoma; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type