Clinical Trial of Green Tea Catechins in Men on Active Surveillance

Prostate Cancer Clinical Trial

Official title:

Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04300855
• Other study ID #: MCC-20056
• Secondary ID: 1R01CA235032-01A
• Status: Recruiting
• Phase: Phase 2
• Start date: August 21, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Nagi Kumar, PhD RD FADA
• Phone: (813) 745-6885
• Email: Nagi.Kumar[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer

Intervention

Drug:
• Sunphenon
The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida
United States	University of Kansas Cancer Center	Westwood	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of Adverse Events per Study Arm	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	Base line to 24 months
Secondary	Adherence of Green Tea Catechins vs.Placebo	Adherence based on pill counts and agent logs	Baseline to 24 months
Secondary	Acceptability of Green Tea Catechins vs.Placebo	Acceptability based on pill counts and agent logs	Baseline to 24 months
Secondary	Change in (prostate-specific antigen) PSA and PSA kinetics	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	Baseline to 24 months
Secondary	Change in gene expression panel	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	Baseline to 24 months
Secondary	Proportion of men with no cancer	Assess the proportion of men with no cancer in the post-intervention biopsy	Baseline to 24 months